Bench Assessment of the Effect of a Collapsible Tube on the Efficiency of a Mechanical Insufflation-Exsufflation Device.

BACKGROUND: Collapsibility of upper airways may impair the efficacy of mechanical insufflation-exsufflation (MI-E) devices. The aim of this study was to determine the effect of a collapsible tube on peak expiratory flow (PEF) when using an MI-E device. METHODS: An MI-E device was attached to a lung simulator. Resistance was set at 5 and 20 cm H2O/L/s (R5, R20) for compliance settings of 20, 40, and 60 mL/cm H2O (C20, C40, C60). A series of 5 cycles were delivered at 3 pressures in the following order: +30/-30, +40/-40, and +50/-50 cm H2O for each compliance/resistance combination with and without the collapsible tube. Each respiratory mechanics profile was tested in random order. Pressure and flow were measured upstream of the MI-E device, and the primary outcome measure was PEF. The relationships of PEF to maximum expiratory pressure were compared with and without the collapsible tube using a linear regression model. RESULTS: For the C20-R5 condition, the effect of the collapsible tube on the intercept (-0.35 cm H2O) was not significant, but this was offset by a significant (and the largest) increase in slope (+0.12 L/s/cm H2O). For the C60-R20 condition, the effect of the collapsible tube on the slope (-0.003 L/s/cm H2O) was not significant, but this was offset by a significant (and the largest) increase of the intercept (+3.16 cm H2O) at 30 cm H2O expiratory pressure. For the other conditions, the collapsible tube significantly increased PEF at 30 cm H2O expiratory pressure, and the gap further increased above this pressure as the slope increased with the collapsible tube. CONCLUSIONS: The collapsible tube resulted in a higher PEF for all respiratory mechanics profiles tested.

Stable pneumorectum using an inline glove - a cost-effective technique to facilitate transanal total mesorectal excision.

AIM: Transanal total mesorectal excision (taTME) is a novel approach for resection of the rectum. Use of a standard insufflator to create pneumorectum, however, results in bellowing-large heaving motions from insufflation of air that can frustrate surgery. We report the successful application of our technique, stable pneumorectum using an inline glove (SPRING), for the performance of transanal rectal excision in a series of 17 patients using a standard laparoscopic insufflator. METHOD: A retrospective review of 17 patients using the SPRING technique was performed between October 2015 and October 2016. Characteristics of these patients were evaluated, and technique-related short-term outcome was reviewed. RESULTS: The SPRING technique was successfully used in patients who underwent both minimally invasive (n = 14) and open (n = 3) approaches in the abdominal stage of the surgery. In the 12 patients who had rectal cancer for whom SPRING was used to facilitate taTME there were no conversions to an alternative access for rectal resection, the median duration of the TME part of the operation was 95 min (62-147) and there was one R1 resection (8%). Billowing was not a significant problem in any of the 17 patients during the surgery. CONCLUSION: In this case series we have successfully shown the feasibility of the SPRING technique as a practical and cost-effective solution to the problem of billowing during taTME.

Assessment of a modified technique for air delivery during fluoroscopic-monitored pneumatic intussusception reduction.

BACKGROUND: Intussusception is one of the most common causes of acute abdominal emergency in children. Image-monitored pressure reduction is the first line of treatment. OBJECTIVE: We report on a modified technique of air delivery during fluoroscopic-monitored pneumatic intussusception reductions, and compare it with an established technique. MATERIALS AND METHODS: We modified the Shiels intussusception reduction device so that the air used for intussusception reduction is delivered not by the device's insufflator bulb, but rather by the hospital medical air supply system, eliminating the need for continuous pumping of the insufflator bulb during the procedure. Subsequently, we retrospectively compared sequential fluoroscopy-monitored pneumatic intussusception reduction procedures performed in patients younger than 18 years using either the standard or modified devices, evaluating technical procedure parameters (i.e. median procedure time length, fluoroscopy time length and radiation dose) and patient outcomes (i.e. number of complete intussusception reductions, number of incomplete intussusception reductions, number of intussusception recurrences within 3 days of the procedure, number of procedures followed by surgery). RESULTS: We found no statistically significant differences between procedures performed with the standard and modified techniques. CONCLUSION: The device modification allows for increased operator comfort. Evaluated procedure parameters and patient outcomes appear similar to those of the standard technique.

Use of Mechanical Insufflation-Exsufflation Devices for Airway Clearance in Subjects With Neuromuscular Disease.

The aim of this systematic review is to examine the benefit/risk ratio of the use of mechanical insufflation-exsufflation (MI-E) devices for airway clearance in patients with neuromuscular diseases. A search was conducted for relevant studies in MEDLINE, the Cochrane Library, and the Health Technology Assessment Database using the main key words: cough, airway clearance, in-exsufflation. The search limits were studies published in English and French between 1970 and 2014 (literature watch until December 2015). The methodological quality of the studies was assessed using (1) the Cochrane Collaboration's risk of bias tool for randomized controlled trials and (2) the Institute of Health Economics' 20-item checklist for comparative and observational studies. Data were extracted into an evidence table according to (1) study design, (2) population characteristics (including age and type of diseases) and intervention (MI-E associated or not with other interventions), (3) outcome measures, and (4) key findings. Twelve studies met the inclusion criteria (4 randomized controlled trials, 3 comparative studies, and 5 observational studies). The quality of the selected studies was poor. None of the studies reported survival outcome. All studies evaluated change of pulmonary function parameters, such as peak expiratory flow. This review underlines the lack of robust data on mechanical medical devices used for airway clearance. The current scientific evidence does not support the use of MI-E for cough augmentation in patients with neuromuscular diseases, but health-care professionals are faced with the reality of medical practice and the absence of alternatives. Most European and American guidelines recommend the use of MI-E despite low-level evidence. However, even if performing comparative trials in a specific population is difficult, the medical device industry should provide reliable data to assist health-care professionals, providers, and payers in the decision-making process. This is the only way to ensure the best treatment for patients.

Effectiveness of a reusable low-cost balloon trocar dissection device in the creation of preperitoneal space during endoscopic surgery. An experimental study in swine.

PURPOSE: To evaluate a new, low-cost, reusable balloon trocar device for dissection of the preperitoneal space during endoscopic surgery. METHODS: Twenty swine (weight: 15-37 kg) were randomized to two groups, according to whether the preperitoneal space was created with a new balloon device manufactured by Bhio-Supply (group B) or with the commercially available OMSPDB 1000® balloon device manufactured by Covidien (group C). Quality and size of the created preperitoneal space, identification of anatomic structures, balloon dissection time, total procedure time, balloon resistance and internal pressure after insufflation with 300 mL of ambient air, balloon-related complications, and procedure cost were assessed. RESULTS: No significant differences in dissection time, total procedure time, or size of the created preperitoneal space were found between the groups. Balloons in group B had a significantly higher internal pressure compared to balloons in group C. None of the balloons ruptured during the experiment. Three animals in group C had balloon-related peritoneal lacerations. Despite a higher individual device cost, group B had a lower procedure cost over the entire experiment. CONCLUSION: The new balloon device is not inferior to the commercially available device in terms of the safety and effectiveness for creating a preperitoneal space in swine.

Effectiveness of a reusable low-cost balloon trocar dissection device in the creation of preperitoneal space during endoscopic surgery. An experimental study in swine

PURPOSE: To evaluate a new, low-cost, reusable balloon trocar device for dissection of the preperitoneal space during endoscopic surgery.METHODS:Twenty swine (weight: 15-37 kg) were randomized to two groups, according to whether the preperitoneal space was created with a new balloon device manufactured by Bhio-Supply (group B) or with the commercially available OMSPDB 1000(r) balloon device manufactured by Covidien (group C). Quality and size of the created preperitoneal space, identification of anatomic structures, balloon dissection time, total procedure time, balloon resistance and internal pressure after insufflation with 300 mL of ambient air, balloon-related complications, and procedure cost were assessed.RESULTS:No significant differences in dissection time, total procedure time, or size of the created preperitoneal space were found between the groups. Balloons in group B had a significantly higher internal pressure compared to balloons in group C. None of the balloons ruptured during the experiment. Three animals in group C had balloon-related peritoneal lacerations. Despite a higher individual device cost, group B had a lower procedure cost over the entire experiment.CONCLUSION:The new balloon device is not inferior to the commercially available device in terms of the safety and effectiveness for creating a preperitoneal space in swine.

Bench Comparative Assessment of Mechanically Assisted Cough Devices.

BACKGROUND: Mechanically assisted cough devices are used in patients with impaired cough to avoid secretion accumulation. We compared 5 mechanically assisted cough devices by bench testing using a breathing simulator and assessed their user-friendliness. METHODS: We measured inspiratory and expiratory airway pressures and peak expiratory flow, the strongest indicator of cough efficacy. We performed 2 bench tests: 1) to ascertain the differences between preset and actual settings in 3 different machines of each mechanically assisted cough device and 2) to assess the effects of varying respiratory impedance and air leaks on performance of the devices. We also evaluated the user-friendliness of the devices by measuring the time required and errors in accomplishing 4 tasks by 10 physicians unfamiliar with mechanically assisted cough devices compared with product specialists from the distributing companies. Physicians also scored the ease of use. RESULTS: Four mechanically assisted cough devices during insufflation and all 5 during exsufflation showed differences between preset and actual airway pressures. All but one device showed uneven actual pressure values between models of the same type. Peak expiratory flow was significantly influenced by the mechanical properties in 2 devices and by air leaks in 4 devices. The median time to accomplish all tasks by the product specialist (10 [interquartile range of 2-29] s) was overall significantly shorter compared with all physicians (from 19 [14-65] to 36 [19-116] s). The number of procedural errors, but not the perceived ease of use, differed significantly between the devices. CONCLUSIONS: The performance of different mechanically assisted cough devices was erratic and included variance between models from the same manufacturer; it was affected by respiratory system impedance and air leaks. Time and rate of errors for performing procedures were elevated. These findings indicate that the devices are not interchangeable and that the settings should be targeted for each patient with the specific machine being used. Improvements in reliability, performance, and user-friendliness are advisable.

Bench assessment of a new insufflation-exsufflation device.

BACKGROUND: The Nippy Clearway is a new mechanical insufflation-exsufflation device used to assist cough. METHODS: We compared the peak expiratory flow (PEF) with the Nippy Clearway versus the CoughAssist in a bench experiment. The relationship between PEF and pressure at the airway opening during exsufflation (minimum expiratory PAO) was investigated under 6 combinations of compliance (30 or 60 mL/cm H2O) (C30 and C60) and resistance (0, 5, or 20 cm H2O/L/s) (R0, R5, and R20) over a 25-50 cm H2O range of set P(AO). The intercepts and slopes of the linear regression performed over PEF and P(AO) relationships were compared for both devices. RESULTS: For the C30R0, C30R5, and C60R5 conditions, the change in both the intercepts and slopes was significant with the Nippy Clearway, compared to the CoughAssist, averaging -2.96 L/s and -0.03 L/s/cm H2O, -1.46 L/s and 0.02 L/s/cm H2O, and -1.02 L/s and -0.04 L/s/cm H2O, respectively. As a result, at any minimum expiratory P(AO), PEF was significantly greater with the Nippy Clearway. For C30R20 and C60R20, the regression lines were similar for the Nippy Clearway and CoughAssist. CONCLUSIONS: In this bench study, PEF with the Nippy Clearway was greater than with the CoughAssist at low respiratory-system compliance.

At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis.

OBJECTIVE: To establish a cost-effective telephone-accessed consultation and mechanical in-exsufflation (MI-E) and manually assisted coughing, oximetry feedback program for 39 patients with amyotrophic lateral sclerosis. DESIGN: Rapid access to healthcare consultation and to MI-E was provided to treat episodes of distress as a result of secretion encumbrance not reversed by suctioning and associated with a decrease in oxyhemoglobin saturation (SpO(2)) baseline. Avoided hospitalizations, defined by relief of respiratory distress and return of SpO(2) baseline to >or=95% by continuous ventilator use and assisted coughing, were recorded. Patient satisfaction was queried at 6 mos, and a cost analysis was performed of continuous vs. on demand MI-E use. RESULTS: Thirty-nine patients made a total of 1661 calls in 7.46 +/- 5.8 mos of follow-up. Twenty-seven patients had 66 home care visits by a respiratory therapist for a total time commitment of 89.7 +/- 99.3 min/patient/mo. Twelve patients, all ventilator users, were also brought mechanical in-exsufflators for mechanically assisted coughing for 47 respiratory episodes. Thirty hospitalizations were avoided. Seventy-five percent of the patients were extremely satisfied. Mean monthly cost per patient for on-demand telephone consultation, professional home healthcare visits, and MI-E as deemed necessary was euro403 +/- euro420 or 59% less than for continuous MI-E rental. Hospitalization costs were also spared. CONCLUSIONS: An on-demand consult and MI-E access program can avoid hospitalizations for patients with amyotrophic lateral sclerosis with significant cost savings.

[Technical aspects of mechanical insufflator-exsufflators. Construction and function of the Emerson CoughAssist]. / Technische Aspekte mechanischer Hustenhilfen. Aufbau und Funktion des Emerson CoughAssist.

The electromechanical insufflator-exsufflator (Emerson CoughAssist) was developed as an aid for patients with neuromuscular disorders suffering from impaired cough. The insufflator-exsufflator simulates and supports physiological cough by supporting inspiration with positive pressure and shifting this positive pressure rapidly into a negative pressure that supports exsufflation and thus bronchial clearance. Maximum pressures are +/- 60 cm H2O, pressures between 30 and 50 cm H2O are sufficient to produce assisted cough in adults with neuromuscular disease. The pressure shift from positive to negative occurs with 0.02 sec and is regulated by a magnetic valve. An anaesthetic facemask is used as interface, alternatively, a mouthpiece can be used in combination with a nose strap. It is also possible to use the insufflator-exsufflator in patients with tracheostomy. We present in this article detailed information about the technical principles and practical use of the electromechanical insufflator-exsufflator.

High-flow laparoscopic insufflators.

In this Update of our July 1995 Evaluation (Health Devices 24[7]), we tested three high-flow laparoscopic insufflators not covered in the original study. In this issue, we are again using the Product Profile Evaluation format that we introduced in our August 1996 (25[8]) Update Evaluation of automated external defibrillators; see the inset on page 14 for a detailed explanation of this new format. In brief, we evaluated the three new units using the same criteria and test methods as in the July 1995 study and rated and ranked the units according to the same overall scheme. Because our criteria and test methods have not changed since the original study, we have not repeated them in this issue; readers should refer to the July 1995 issue for that information. Instead, in a series of Product Profiles, we present the characteristics, test results, and ratings for each newly evaluated unit individually. Following the profiles, a comprehensive Conclusions section details how the newly evaluated units compare with those evaluated in our original study. One of the units evaluated in this issue is rated Acceptable. The other two are rated Conditionally Acceptable because of their inability to provide adequate pressure relief; a secondary gas source should not be applied in the pneumoperitoneum while these units are in use. Of the 16 units we have evaluated to date, nine are rated Acceptable and seven are rated Conditionally Acceptable.

Twenty-two years of office and outpatient laparoscopy: current techniques and why I chose them.

Since 1972 I have introduced the following technical modifications in outpatient laparoscopy under local anesthesia to improve safety, economy, and patient acceptability: avoiding the insufflating needle and sharp trocar in favor of open abdominal entry, using the Hasson cannula; introducing room air for insufflation instead of nitrous oxide or carbon dioxide; using the Hulka clip in place of tubal coagulation; making a single-incision, open surgical entry through the central umbilical fossa in obese patients; and completing fascial penetration with a blunt hemostat or Kelly clamp to minimize the risk of bowel or vessel injury.

[The hypothesis of a diagnostic-prognostic assessment of intestinal invagination with the aim of treatment by echo-guided pneumatic reduction]. / Ipotesi di valutazione diagnostico-prognostica della invaginazione intestinale finalizzata al trattamento con riduzione pneumatica ecoguidata.

The authors investigated the role of US in the diagnostic-prognostic evaluation of enteric intussusception, for the use of US-guided pneumatic reduction (RPEG). In the last 5 years, 59 young patients were examined; 44 of them had clinically suspected enteric intussusception which was confirmed by US. US allowed site and nature of the condition to be demonstrated (sensitivity and specificity: 100%), while supplying helpful predictive prognostic elements as to the extent of intussuscepted loop involvement (predictive prognostic value: 100%). On the contrary, its etiological screening capabilities were poor (11%) in the identification of secondary forms (5 ileal diverticula). A grading score was introduced to select the patients undergoing RPEG. Six clinical and US parameters were considered, with values increasing according to severity of the condition. The higher the score, the lower the chances of therapeutical success with RPEG. In 3 cases (2 loop necroses and 1 severe intestinal obstruction) with US score greater than 6 [9] and clinical score greater than 11 [15], RPEG, was replaced by surgery. Fourteen patients underwent RPEG: positive results were obtained in 12 cases (85%). In one case, a short-term relapse (within 6 hours) was observed.