Gunshot damage to monoplace hyperbaric chamber acrylic.

Introduction: Health care workers are vulnerable to workplace violence, including active shooter incidents. Little is known about how firearms could damage monoplace chamber acrylic and whether a breached pressurized chamber presents additional threat to the patient or bystanders. Methods: In a remote area where firearm discharge is permitted, we tested the durability of sections of monoplace hyperbaric chamber acrylic under various firearm discharges. Firearms were discharged at acrylic sections from a distance of 17 feet at 45 degrees and 10 degrees from perpendicular while wearing protective gear. Firearm calibers ranged from .22 caliber handgun to 5.56 mm AR-15 rifle. We also conducted similar testing on a monoplace hyperbaric chamber pressurized with >99% oxygen to a differential pressure of 14.7 psig (2.0 atmospheres absolute at sea level). Handguns were remotely fired at a distance of 12 feet from the chamber (30 degrees from perpendicular), while the rifles were fired at a distance of 60 feet from the chamber. Result: Higher-caliber handguns penetrated or fractured the acrylic sections only after multiple shots. The tested rifles caused full-thickness penetration and fracture with a single shot. However, the pressurized monoplace hyperbaric chamber required two shots from the AR-15 rifle, separated by approximately 60 mm, to penetrate the acrylic, resulting in rapid depressurization. The chamber otherwise remained intact, with no explosion or conflagration observed. Conclusion: An intact or pressurized chamber performs differently than stand-alone acrylic sections under firearms testing. In a worst-case active shooter scenario, the pressurized monoplace chamber tested posed no additional threat to bystanders beyond the significant risk of ricochet.

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms.

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen.

INTRODUCTION: Global outcomes can strengthen inferences from clinical trials. We evaluate global outcomes for persistent post-concussive symptoms (PCS) after mild traumatic brain injury (mTBI) in two clinical trials of hyperbaric oxygen (HBO2) in United States service members. METHODS: During study design, outcomes of symptom, cognitive, and functional impairments planned for a trial of HBO2 for PCS (HOPPS) were weighted and grouped into different domains to formulate the composite outcome total score. The composite outcome was compared between the intervention groups in HOPPS and those in a subsequent HBO2 trial (BIMA) for validation. Additionally, two post hoc global outcome measures were explored, including one composed of components that demonstrated favorable characteristics in both studies and another via components used in another TBI randomized trial (COBRIT). RESULTS: In total, 143 active-duty or veteran military personnel were randomized across the two studies. Composite total scores improved from baseline for HBO2 (mean ± SD -2.9±9.0) and sham (-2.9±6.6) groups in HOPPS but did not differ significantly between groups (p=0.33). In BIMA, 13-week changes from baseline favored the HBO2 group (-3.6±6.4) versus sham (-0.3±5.2; p=0.02). No between-group differences were found when COBRIT composite scoring was applied to BIMA. Overall, HBO2 effects were maximized when the post hoc global measure derived from both studies was applied to the data. CONCLUSIONS: Composite total scores in HOPPS and BIMA were consistent with primary study results. The global measures considered may offer utility as endpoints to achieve maximal HBO2 effect in future trials of the mTBI population. IDS: clinicaltrials.gov Identifiers NCT01611194 (BIMA) and NCT01306968 (HOPPS).

Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms.

To date, several Department of Defense (DoD) and civilian studies have evaluated hyperbaric oxygen for mild forms of traumatic brain injury. Prior to the DoD-sponsored "Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA)" trial, none included post-intervention follow-up beyond three to six months. Post-hoc attempts at long-term follow-up were complicated by low participation and potential self-selection bias. BIMA planned for follow-up through 12 months but was amended to add post-concussive and post-traumatic stress disorder, quality of life, pain, depression, anxiety, and alcohol use assessments at 24 and 36 months. A total of 42 of 71 BIMA participants consented to extendedfollow-up, and 40 and 14 completed a 24- or 36-month visit, respectively, representing an overall response rate of 59% and 20%. Participants who completed extended follow-up were similar to the study group that did not in terms of demographics, perceived intervention allocation, and initial response to intervention. There were no significant differences at 24 or 36 months between intervention groups, and group mean scores were near pre-intervention values. This return to baseline could be due to waning treatment effect, selection bias, or participant or perception effects. Though BIMA implemented several participant retention strategies, more frequent participant contact and increased compensation might improve long-term retention in future studies. clinicaltrials.gov Identifier NCT01611194.

Hyperbaric oxygen for mTBI-associated PCS and PTSD: Pooled analysis of results from Department of Defense and other published studies.

BACKGROUND: Some clinical trials report improvement in persistent post-concussive symptoms (PCS) with hyperbaric oxygen (HBO2) following mild traumatic brain injury (mTBI), but questions remain regarding the utility of HBO2 for PCS, the effects of HBO2 on post-traumatic stress disorder (PTSD), and the influences of sham control exposures. METHODS: A systematic review and pooled analysis was conducted to summarize available evidence for HBO2 in mTBI-associated PCS ± PTSD. Data aggregated from four Department of Defense (DoD) studies with participant-level data (n=254) were grouped into pooled HBO2 and sham intervention groups. Changes from baseline to post-intervention on PCS, PTSD, and neuropsychological measures were assessed using linear mixed models to evaluate main intervention and intervention-by-baseline PTSD effects. Potential dose-response relationships to oxygen partial pressures were investigated. Intervention effects from three other published studies with summary-level participant data (n=135) were also summarized.. RESULTS: Pooled DoD data analyses indicated trends toward improvement favoring HBO2 for PCS (Rivermead Total Score: -2.3, 95% CI [-5.6, 1.0], p=0.18); PTSD (PTSD Checklist Total Score: -2.7, 95% CI [-5.8, 0.4], p=0.09); and significant improvement in verbal memory (CVLT-II Trial 1-5 Free Recall: 3.8; 95% CI [1.0, 6.7], p=0.01). A dose-response trend to increasing oxygen partial pressure was also found, with a greater HBO2 effect in mTBI-associated PTSD suggested. The direction of results was consistent with other published studies. CONCLUSION: A definitive clinical trial, with an appropriate control group, should be considered to identify the optimal HBO2 dosing regimen for individuals with mTBI-associated PTSD ± PCS.

Longitudinal study of hyperbaric oxygen intervention on balance and affective symptoms in military service members with persistent post-concussive symptoms.

BACKGROUND: Dizziness and imbalance are common after mild traumatic brain injury (mTBI). Hyperbaric oxygen (HBO2) has been proposed for persistent post-concussive symptoms after mTBI, but its effect on vestibular function is unknown. OBJECTIVE: To describe balance function in military service-members before and after intervention, and to explore the influence of post-traumatic stress disorder (PTSD), anxiety, and depression on vestibular outcomes. METHODS: Seventy-one participants with mTBI and seventy-five healthy adults without brain injury were enrolled (NCT01611194 and NCT01925963). mTBI participants were randomized to 40 HBO2 sessions or 40 sham chamber sessions over 12 weeks. Normative controls received no intervention. Balance and neuropsychological function were measured at baseline, 13 weeks, and 6 months. RESULTS: The mTBI cohort performed worse than healthy controls on balance and gait measures and reported more affective symptoms. Some within-group improvements were noted at 13 weeks and 6 months. Significant between-intervention differences on balance measures were minimal but effects on postural control generally favored HBO2. Those with affective symptoms, particularly PTSD, had the most improvement in postural control and otolith function following 13 weeks of HBO2. CONCLUSION: HBO2 may influence balance function after mTBI, particularly in those with affective symptoms.

Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial.

BACKGROUND: In prior military randomized trials, participants with persistent symptoms after mild traumatic brain injury (TBI) reported improvement regardless of receiving hyperbaric oxygen (HBO2) or sham intervention. This study's objectives were to identify outcomes for future efficacy trials and describe changes by intervention. METHODS: This Phase II, randomized, double-blind, sham-controlled trial enrolled military personnel with mild TBI and persistent post-concussive symptoms. Participants were randomized to receive 40 HBO2 (1.5 atmospheres absolute (ATA), ⟩99% oxygen, 60 minutes) or sham chamber sessions (1.2 ATA, room air, 60 minutes) over 12 weeks. Participants and evaluators were blinded to allocation. Outcomes assessed at baseline, 13 weeks and six months included symptoms, quality of life, neuropsychological, neurological, electroencephalography, sleep, auditory, vestibular, autonomic, visual, neuroimaging, and laboratory testing. Participants completed 12-month questionnaires. Intention-to-treat results are reported. RESULTS: From 9/11/2012 to 5/19/2014, 71 randomized participants received HBO2 (n=36) or sham (n=35). At baseline, 35 participants (49%) met post-traumatic stress disorder (PTSD) criteria. By the Neurobehavioral Symptom Inventory, the HBO2 group had improved 13-week scores (mean change -3.6 points, P=0.03) compared to sham (+3.9 points). In participants with PTSD, change with HBO2 was more pronounced (-8.6 vs. +4.8 points with sham, P=0.02). PTSD symptoms also improved in the HBO2 group, and more so in the subgroup with PTSD. Improvements regressed at six and 12 months. Hyperbaric oxygen improved some cognitive processing speed and sleep measures. Participants with PTSD receiving HBO2 had improved functional balance and reduced vestibular complaints at 13 weeks. CONCLUSIONS: By 13 weeks, HBO2 improved post-concussive and PTSD symptoms, cognitive processing speed, sleep quality, and balance function, most dramatically in those with PTSD. Changes did not persist beyond six months. Several outcomes appeared sensitive to change; additional studies are warranted.

Carboxyhemoglobin half-life during hyperbaric oxygen in a patient with lung dysfunction: a case report.

INTRODUCTION: The carboxyhemoglobin half-life (COHb t1/2) during hyperbaric oxygen (HBO2) is often quoted as 23 minutes, derived from the average of two adult male volunteers breathing HBO2 at 3 atmospheres absolute (ATA). However, the mean COHb t1/2 of 12 male volunteer smokers was 26.3 minutes at 1.58 ATA and in 12 non-intubated carbon monoxide (CO) poisoned patients treated at 3 ATA, was 43 minutes. CASE REPORT: An 81-year old male, poisoned by an improperly ventilated natural gas heater, was intubated for coma, then treated with HBO2. His PaO2/FiO2 = 283 from aspiration. His initial COHb was 34.4%, and 18 minutes before HBO2, 5.9%. After a compression interval of 17 minutes, the COHb measured after 22 minutes at 3 ATA was 3.3%. RESULTS: By exponential decay, his COHb t1/2 before HBO2 was 95 minutes. We estimate the range for COHb t1/2 during compression as 62-81 minutes and for the 3-ATA interval, 58 to 49 minutes, respectively. The mid-point estimate of COHb t1/2 at 3 ATA was 53 minutes. CONCLUSIONS: The COHb t1/2 we calculated is greater than previously reported, but longer in our patient possibly because of concomitant respiratory failure, lung dysfunction, and mechanical ventilation. The often-cited COHb t1/2 of 23 minutes, likely underestimates the actual COHb t1/2 in CO-poisoned patients, especially those with cardiopulmonary dysfunction.

Rates of visual acuity change in patients receiving hyperbaric oxygen in monoplace and multiplace chambers.

INTRODUCTION: Changes in visual acuity are a known side effect of hyperbaric oxygen (HBO2). We conducted a quality improvement initiative to better quantify visual change risk and to identify possible risk factors. METHODS: Vision was checked weekly in a clinical HBO2 population by Snellen eye chart. Visual acuity change was defined as Snellen test worsened to 20/40 or greater or by loss of 2 lines. RESULTS: Of 85 patients treated from January 2013 to February 2015 with 10 HBO2 sessions and ≥ 2 weeks of visual acuity testing, 53 (62%) were male. All were treated for UHMS-approved indications. A total of 34 patients (40%) had no change in visual acuity, 27 (32%) had a 1-line change, and 24 (28%) had at least a 2-line worsening in visual acuity. The number of sessions for those with at least a 2-line change was 36 ± 15 (15-60). A 2-line change occurred at similar rates for monoplace and multiplace patients (29% and 32%, respectively), but monoplace patients more frequently reached 20/40 or worse (32% vs. 18%). Seven of 11 patients with existing cataracts had ≥ 2 line change, as did six of 14 patients (43%) with a history of head/neck radiation. CONCLUSIONS: In this retrospective review of quality improvement data, 28% of patients had a 2-line change in visual acuity by Snellen exam after treat-ment with HBO2. Further study of possible risk factors, including chamber type, is warranted.

Ischemic colitis associated with acute carbon monoxide poisoning--a case report.

Carbon monoxide (CO) poisoning is common, but it has rarely been reported to cause ischemic colitis. In this case, a 34-year-old female with depression presented to an emergency department after a period of unconsciousness, with urinary and bowel incontinence, following exposure to car exhaust. Her carboxyhemoglobin level was 23%. She had metabolic acidosis. She was transferred to our facility for hyperbaric oxygen treatment, where she had intractable nausea/vomiting with abdominal pain and bright-red bleeding per rectum. She exhibited lower abdominal tenderness and hypoactive bowel sounds. Vital signs were: temperature 36.8 degrees C; blood pressure 137/ 86 mmHg; heart rate 114 beats/minute; respiratory rate 28 breaths/minute. The patient's electrocardiogram showed sinus tachycardia with T-wave inversions in leads I, aVL and V3-V6. The troponin I level peaked at 3.7 ng/ml. Echocardiogram showed a reduced ejection fraction of 30%-35%, with akinesis in the posterior lateral and distal anterior distributions. Computed tomography of the abdomen revealed diffuse colonic mural thickening, supporting mesenteric ischemia. Sigmoidoscopy showed edematous friable pale mucosa from rectum to distal sigmoid colon. Hyperbaric oxygen was deferred based on the patient's status. Over three days, the initial hematochezia progressed to melena and then resolved. Adenosine cardiac stress MRI was normal. She was transferred to the psychiatry service and discharged four days later. Four years later, she has no gastrointestinal, cardiac or cognitive problems.

Simple and Procedural Reaction Time for Mild Traumatic Brain Injury in a Hyperbaric Oxygen Clinical Trial.

Simple reaction time (SRT) and procedural reaction time (PRT) are speed-of-processing tasks in the Automated Neuropsychological Assessment Metrics (ANAM) that may be sensitive to mild traumatic brain injury (mTBI). The investigators measured SRT and PRT throughput (correct responses per minute) at baseline, 6 weeks, and 13 weeks in military personnel with mTBI randomized to local care or 40 chamber sessions (sham-1.2 atmospheres absolute [ATA] air, hyperbaric oxygen-1.5 ATA O2). Scores were assessed at baseline using univariate analysis of variance and across time with repeated measures methods. Data reported as throughput standard scores (mean = 100, SD = 15). Seventy-two participants with ongoing symptoms after mTBI enrolled in the study (three female, median age 31 years, mean three lifetime concussion events, most recent mTBI 23 months prior). Sixty-four had Automated Neuropsychological Assessment Metrics data at 13 weeks. SRT and PRT throughput standard scores were comparable across groups at baseline. Over time, SRT scores did not change in the hyperbaric oxygen or sham groups and decreased in the local care group. PRT throughput standard scores increased from baseline to mid-intervention and decreased from mid-intervention to postintervention in all groups. Repeated measures change over time in SRT (p = 0.23), and PRT (p = 0.17) scores were not different among groups. This study may be underpowered to detect statistically significant change.

Performance of three large-volume infusion pumps with the monoplace hyperbaric chamber.

We evaluated the Zyno Medical Z-800F, CME Body Guard 323 Color Vision, and Baxter Flo-Gard 6201 infusion pumps for monoplace chamber conditions. We adjusted pump occlusion pressure allowing infusion to 3 atmospheres absolute (atm abs). Baxter and Zyno pumps were connected to the chamber pass-through with rigid small-bore tubing. The CME infusion set was connected directly to the pass-through. We infused saline to a collection manifold inside a monoplace chamber at 1-100 mL/ hour under pressures ranging from 0.85-3.0 atm abs. We averaged results from three to five separate tests for each condition. At baseline, pumps performed within ±10% of expected (our measurement capability). However, clinical engineering verified performance within manufacturer specifications (±5% at atmospheric pressure). During a carbon monoxide hyperbaric protocol (3 atm abs/2 atm abs), measured flow with the Baxter, CME and Zyno pumps was ±5% of setting at 10 mL/hour (95%, 103%, 95%, respectively); at 1 mL/hour, average flow were 91%, 83%, 83%, respectively. During timed testing (volume recorded before decompression), pump accuracy was ±10% at 10 and 100 mL/hour. Tubing compliance compromised performance at lower flow rates, magnified by increased pressure. These pumps have potential for monoplace chamber use, although not supported by the manufacturers or FDA-cleared. At low flow rates, tubing compliance affects delivered volumes.

Executive summary: The Brain Injury and Mechanism of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) Study.

The Brain Injury and Mechanism of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) study, sponsored by the Department of Defense and held under an investigational new drug application by the Office of the Army Surgeon General, is one of the largest and most complex clinical trials of hyperbaric oxygen (HBO2) for post-concussive symptoms (PCS) in U.S. military service members.

Hyperbaric oxygen for persistent post-concussive symptoms: long-term follow-up.

We report results of an observational cohort study investigating long-term follow-up in participants from two completed United States military trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms (PCS), as well as challenges in recruitment and retention in active-duty military personnel. After informed consent, participants completed an electronic survey assessing PCS, post-traumatic stress disorder (PTSD), anxiety, depression and quality of life. Of 132 HBO2 study participants, 40 (30%) completed the survey (42 could not be contacted; 50 were lost to follow-up or declined). All were male, age 28.1 ±6.6 years (mean ±1SD). Time to follow-up was 39.2 ±6.1 months. At follow-up, participants reported continued symptoms of PTSD, depression, anxiety and reduced quality of life. Among DARPA/VCU study participants, total PCS scores worsened in the 1.5 atmospheres absolute (ATA) equivalent HBO2 group (mean change 7.4 ±15.8) and improved in the sham (-8.0 ±7.7) and 2.0 atmospheres absolute equivalent HBO2 groups (-3.3 ±7.4). Individual changes varied widely, range -23 to +28 points. In participants from the HOPPS study, total PCS scores worsened in all groups: local care (10.5 ±8.7), sham (7.9 ±11.9) and 1.5 ATA HBO2 (1.0 ±19.4). In this limited, cross-sectional sample, PCS and PTSD symptoms did not appear to improve over time by descriptive analyses. Low participation rates and potential response bias limit our ability to perform statistical hypothesis testing and to draw conclusions from these data. Future studies should prospectively plan longitudinal follow-up and regular engagement with participants to minimize attrition.

Carbon monoxide poisoning in Utah: 1996-2013.

INTRODUCTION: The true incidence of carbon monoxide (CO) poisoning is not clearly known, but a description of possible trends could aid in prevention. METHODS: Investigators searched Utah state databases for emergency department (ED) visits and admissions for CO poisoning and medical examiner records for CO-related fatalities. RESULTS: From 1996-2013, 7,590 individuals were diagnosed with CO poisoning: 6,469 were treated/ released from EDs; 596 were admitted; 525 died. Of 7,065 non-fatal poisonings, 5,950 (84%) were accidental and 498 (7%) were suicide attempts. Few patients (9.7%) were treated with hyperbaric oxygen. For accidental poisonings, internal combustion engines accounted for 43%, smoke inhalation, 34%, and heating sources, 22%. Internal combustion engines were implicated in 97% of suicide attempts. Non-fatal poisonings declined following a 2008 legislative change requiring CO alarms in residences, but we do not know if legislation caused the decline. One hundred forty-one (27%) fatal poisonings were accidental, 361 (70%) suicides and two (0.4%) homicides. Victims with cardiovascular autopsy findings/past cardiovascular history had lower carboxyhemoglobin levels (mean 51.2%, n=53) compared to those without (70.8%, n=472). Mean postmortem carboxyhemoglobin was highest in ages 20-29 years (72.5%). CONCLUSIONS: The incidence of CO poisoning in Utah is declining, but CO poisoning is still common. Alarm legislation may aid prevention efforts. An educational campaign addressing the many causes and circumstances of CO poisoning is required for prevention.

Spontaneous cerebral gas embolism and pulmonary arteriovenous malformation: a case report.

Pulmonary barotrauma can cause cerebral arterial gas embolism (CAGE) from pulmonary overdistension of alveoli forcing gas into the pulmonary vasculature. We report a case of CAGE in a man found to have occult pulmonary arteriovenous malformation (PAVM) and undiagnosed obstructive sleep apnea (OSA). A 46-year-old man was admitted to the hospital for an acute seizure and left-sided weakness, with telangiectasias on his lower lip and tongue. Brain-computed tomography (CT) showed gas emboli in the right hemisphere. Chest CT revealed a 1.8-cm PAVM in the posterior right costophrenic sulcus. A transthoracic echocardiogram showed no intracardiac shunt or patent foramen ovale. He was treated with phenytoin, lidocaine and hyperbaric oxygen. The PAVM was occluded with a detachable balloon followed by coil embolization. Polysomnography revealed severe obstructive sleep apnea, which was treated with CPAP. Seven years later, the patient was functioning at his pre-event baseline. We propose the CAGE was caused by high negative intrathoracic pressures while breathing against an obstructed upper airway, with air entrainment into the PAVM and subsequent arterialization.

Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial.

IMPORTANCE: Improvement has been anecdotally observed in patients with persistent postconcussion symptoms (PCS) after mild traumatic brain injury following treatment with hyperbaric oxygen (HBO). The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date. OBJECTIVES: To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone, care supplemented with HBO, or a sham procedure. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado, North Carolina, California, and Georgia between April 26, 2011, and August 24, 2012. Assessments occurred before randomization, at the midpoint, and within 1 month after completing the interventions. INTERVENTIONS: Routine PCS care was provided in specialized clinics. In addition, participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute (ATA), 40 sham sessions consisting of room air at 1.2 ATA, or no supplemental chamber procedures. MAIN OUTCOMES AND MEASURES: The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) served as the primary outcome measure. A change score of at least 2 points on the RPQ-3 subscale (range, 0-12) was defined as clinically significant. Change scores from baseline were calculated for the RPQ-3 and for the total RPQ. Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing. RESULTS: On average, participants had sustained 3 lifetime mild traumatic brain injuries; the most recent occurred 23 months before enrollment. No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (mean change score, 0.5; 95% CI, -4.8 to 5.8; P = .91), both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ (mean change score, 5.4; 95% CI, -0.5 to 11.3; P = .008 in the HBO group and 7.0; 95% CI, 1.0-12.9; P = .02 in the sham group). No difference between the HBO group and the sham group was observed (P = .70). Chamber sessions were well tolerated. CONCLUSIONS AND RELEVANCE: Among service members with persistent PCS, HBO showed no benefits over sham compressions. Both intervention groups demonstrated improved outcomes compared with PCS care alone. This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01306968.

Performance of the Hospira Plum A+ (HB) hyperbaric infusion pump.

BACKGROUND: We evaluated the Hospira Plum A+ (HB) hyperbaric infusion pump under monoplace and multiplace hyperbaric conditions to test pump flow accuracy. METHODS: Pump flow accuracy was tested in monoplace and multiplace hyperbaric chambers at different rates, fluid viscosities, pressures and volumes. Output was recorded from the pump (programmed) and from graduated cylinders or syringes (actual). The lead acid battery life was recorded for multiplace trials. RESULTS: In monoplace trials to 3.0 atmospheres absolute (atm abs), the pump functioned within the published tolerance of 12.5% at 1 ml/hour (mean deviation +3.3%, range 0.0% to +5.0%) and at faster flow rates (mean deviation -0.4%, range -11.5% to +6.0%). A trial of packed red blood cells (deviation -3.3%) was also within acceptable limits. For all multiplace trials, the pump functioned well within the manufacturer's limits (mean deviation -0.1%, range -0.8% to +0.9%). At the maximum flow rate, the interval to the first battery alarm for two trials was shorter than the duration of a clinical hyperbaric session (first alarm at 82 and 94 minutes). When we examined delivery variances in the compression and decompression phases for monoplace chambers, at 1 ml/hour 25/39 trials (64%) had no measurable infusion volume during compression. Conversely, more than twice the programmed volume was infused during the 10-minute decompression interval (mean 0.40 ml, range 0.32 to 0.60 ml). The tubing compliance effect was also noted, to a lesser degree, in trials at 3 and 5 ml/hour. CONCLUSIONS: This infusion pump can be useful in hyperbaric medicine departments that treat patients who need intravenous infusions. Tubing compliance may affect fluid volumes delivered by the pump, especially when delivery rates are low. Careful monitoring of patients with low volume infusions during monoplace chamber compression and decompression is advised.