Atypical sleep in critically ill patients on mechanical ventilation is associated with increased mortality.

Sleep patterns in critically ill patients' polysomnographic sleep studies (PSG) are severely abnormal. PURPOSE: We aimed to investigate the association of atypical sleep patterns, micro-sleep phenomena (sleep spindles and K-complexes) and rapid eye movement (REM) sleep with intensive care unit (ICU), in-hospital and 90-day mortality in conscious critically ill patients on mechanical ventilation. METHOD: This was a prospective descriptive study. We analysed 52 PSGs recorded in conscious critically ill patients on mechanical ventilation. PSGs were scored according to standard classification when possible. Otherwise, modified classification proposed for scoring sleep in critically ill patients was used. The association of PSG findings with mortality was studied using logistic regression and Weibull model of survival analysis. RESULTS: The presence of atypical sleep patterns in accordance with modified sleep scoring classification was associated with higher odds for ICU mortality (odds ratio 11.63; p = 0.03). The absence of K-complexes was associated with higher odds for ICU mortality (odds ratio 11.63; p = 0.03), while the absence of sleep spindles was associated with higher odds for in-hospital (odds ratio 7.80; p = 0.02) and 90-day mortality (odds ratio 5.51; p = 0.02). Loss of sleep spindles was associated with higher mortality risk with cutoff point 90 days (hazard ratio 3.87; p = 0.03). CONCLUSIONS: The presence of atypical sleep and absence of normal PSG sleep characteristics in conscious critically ill patients on mechanical ventilation indicates involvement of sleep producing brain structures in the pathological process and is associated with poor outcome.

From acute to chronic pain after thoracic surgery: the significance of different components of the acute pain response.

PURPOSE: Acute postoperative pain is a strong predictor for postthoracotomy pain syndrome (PTPS), but the mechanism is unknown. Even though thoracic pain is usually considered the dominating acute pain after thoracic surgery, up to 45% of patients consider shoulder pain to be dominating pain and often this shoulder pain is referred visceral pain. This study aims to examine which components of the acute pain response after thoracic surgery were associated with PTPS and if any signs of a generalized central hypersensitivity could be identified in patients with PTPS. PATIENTS AND METHODS: In a prospective cohort study, 60 consecutive patients for lobectomy were included and examined preoperatively and 12 months postoperatively for pain and signs of hypersensitivity using a comprehensive protocol for quantitative sensory testing. Thoracic pain, shoulder pain, referred pain, and overall pain were assessed five times daily during the first four postoperative days. RESULTS: Sixteen patients (31% of the 52 patients who completed the study) developed PTPS. Thoracic pain was the only pain component that was associated with PTPS and was a stronger predictor for PTPS than overall pain. There were no signs of hypersensitivity before or after the operation in patients with PTPS, but patients with PTPS more often suffered from preoperative pain. CONCLUSION: Thoracic pain was the only component of the acute pain response that predicted PTPS and was a stronger predictor than overall pain.

Satisfaction with quality of ICU care for patients and families: the euroQ2 project.

BACKGROUND: Families' perspectives are of great importance in evaluating quality of care in the intensive care unit (ICU). This Danish-Dutch study tested a European adaptation of the "Family Satisfaction in the ICU" (euroFS-ICU). The aim of the study was to examine assessments of satisfaction with care in a large cohort of Danish and Dutch family members and to examine the measurement characteristics of the euroFS-ICU. METHODS: Data were from 11 Danish and 10 Dutch ICUs and included family members of patients admitted to the ICU for 48 hours or more. Surveys were mailed 3 weeks after patient discharge from the ICU. Selected patient characteristics were retrieved from hospital records. RESULTS: A total of 1077 family members of 920 ICU patients participated. The response rate among family members who were approached was 72%. "Excellent" or "Very good" ratings on all items ranged from 58% to 96%. Items with the highest ratings were concern toward patients, ICU atmosphere, opportunities to be present at the bedside, and ease of getting information. Items with room for improvement were management of patient agitation, emotional support of the family, consistency of information, and inclusion in and support during decision-making processes. Exploratory factor analysis suggested four underlying factors, but confirmatory factor analysis failed to yield a multi-factor model with between-country measurement invariance. A hypothesis that this failure was due to misspecification of causal indicators as reflective indicators was supported by analysis of a factor representing satisfaction with communication, measured with a combination of causal and reflective indicators. CONCLUSIONS: Most family members were moderately or very satisfied with patient care, family care, information and decision-making, but areas with room for improvement were also identified. Psychometric assessments suggest that composite scores constructed from these items as representations of either overall satisfaction or satisfaction with specific sub-domains do not meet rigorous measurement standards. The euroFS-ICU and other similar instruments may benefit from adding reflective indicators.

Shoulder Pain After Thoracic Surgery: Type and Time Course, a Prospective Cohort Study.

OBJECTIVES: To study the time course of ipsilateral shoulder pain after thoracic surgery with respect to incidence, pain intensity, type of pain (referred versus musculoskeletal), and surgical approach. DESIGN: Prospective, observational cohort study. SETTING: Odense University Hospital, Denmark. PARTICIPANTS: Sixty patients for major lung resection. INTERVENTIONS: Postoperative observation of ipsilateral shoulder pain. MEASUREMENTS AND MAIN RESULTS: Postoperative numeric rating scale score of shoulder pain and thoracic pain and postoperative examination of the sites of shoulder pain for musculoskeletal involvement (muscle tenderness on palpation and movement) with follow-up 12 months after surgery. Clinically relevant pain was defined as a numeric rating scale score>3. Of the 60 patients included, 47 (78%) experienced ipsilateral shoulder pain, but only 25 (42%) reported clinically relevant shoulder pain. On postoperative day 4, 19 patients (32%) still suffered shoulder pain, but only 4 patients (7%) had clinically relevant pain. Four patients (8%) still suffered shoulder pain 12 months after surgery. In 26 patients (55%), the shoulder pain was classified as referred versus 21 patients (45%) who suffered shoulder pain of the musculoskeletal type. Shoulder pain of the musculoskeletal type was significantly more intense (p = 0.0008) than referred shoulder pain. CONCLUSION: Only a subset of patients has clinically relevant shoulder pain after postoperative day 2. Chronic shoulder pain is a minor problem after lobectomy and previously may have been overestimated. Ipsilateral shoulder pain of the musculoskeletal type is more intense than referred ipsilateral shoulder pain.

Families' experiences of intensive care unit quality of care: Development and validation of a European questionnaire (euroQ2).

PURPOSE: The purpose of the study is to adapt and provide preliminary validation for questionnaires evaluating families' experiences of quality of care for critically ill patients in the intensive care unit (ICU). MATERIALS AND METHODS: This study took place in 2 European ICUs. Based on literature and qualitative interviews, we adapted 2 previously validated North American questionnaires: "Family Satisfaction with the ICU" and "Quality of Dying and Death." Family members were asked to assess relevance and understandability of each question. Validation also included test-retest reliability and construct validity. RESULTS: A total of 110 family members participated. Response rate was 87%. For all questions, a median of 97% (94%-99%) was assessed as relevant, and a median of 98% (97%-100%), as understandable. Median ceiling effect was 41% (30%-47%). There was a median of 0% missing data (0%-1%). Test-retest reliability showed a median weighted κ of 0.69 (0.53-0.83). Validation showed significant correlation between total scores and key questions. CONCLUSIONS: The questions were assessed as relevant and understandable, providing high face and content validity. Ceiling effects were comparable to similar instruments; missing data, low; and test-retest reliability, acceptable. These measures are promising for use in research, but further validation is needed before they can be recommended for routine clinical use.

Changing the needle for lumbar punctures: results from a prospective study.

OBJECTIVE: Post-dural puncture headache (PDPH) is a common complication of diagnostic lumbar punctures. Both a non-cutting needle design and the use of smaller size needles have been shown to greatly reduce the risk of PDPH. Nevertheless, larger cutting needles are still widely used. This study describes the process of changing the needle in an outpatient clinic of a Danish neurology department. METHODS: Prospective interventional trial. Phase 1: 22G cutting needle. Phase 2: 25G non-cutting needle. Practical usability of each needle was recorded during the procedure, while the rate of PDPH and the occurrence of socioeconomic complications were acquired from a standardized questionnaire. RESULTS: 651 patients scheduled for diagnostic lumbar punctures were screened for participation and 501 patients were included. The response rate was 80% in both phases. In phase 2, significant reductions were observed in occurrence of PDPH (21 vs. 50, p=0.001), number of days spent away from work (55 vs. 175, p<0.001), hospitalizations (2 vs. 17, p<0.001), and number of bloodpatch treatments (2 vs. 10, p=0.019). Furthermore, during the procedure, both the need for multiple attempts (30% vs. 44%, p=0.001), and the failure-rate of the first operator (17% vs. 29%, p=0.005) were reduced. CONCLUSIONS: Our study showed that smaller, non-cutting needles reduce the incidence of PDPH and are easily implemented in an outpatient clinic. Changing the needle resulted in fewer socioeconomic complications and fewer overall costs, while also reducing procedural difficulty.

Early visceral pain predicts chronic pain after laparoscopic cholecystectomy.

Chronic pain after laparoscopic cholecystectomy is related to postoperative pain during the first postoperative week, but it is unknown which components of the early pain response is important. In this prospective study, 100 consecutive patients were examined preoperatively, 1 week postoperatively, and 3, 6, and 12 months postoperatively for pain, psychological factors, and signs of hypersensitivity. Overall pain, incisional pain (somatic pain component), deep abdominal pain (visceral pain component), and shoulder pain (referred pain component) were registered on a 100-mm visual analogue scale during the first postoperative week. Nine patients developed chronic unexplained pain 12 months postoperatively. In a multivariate analysis model, cumulated visceral pain during the first week and number of preoperative biliary pain attacks were identified as independent risk factors for unexplained chronic pain 12 months postoperatively. There were no consistent signs of hypersensitivity in the referred pain area either pre- or postoperatively. There were no significant associations to any other variables examined. The risk of chronic pain after laparoscopic cholecystectomy is relatively low, but significantly related to the visceral pain response during the first postoperative week.

Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial.

BACKGROUND: Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. METHODS AND DESIGN: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. DISCUSSION: This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01209663.

Challenges in end-of-life decisions in the intensive care unit: an ethical perspective.

When making end-of-life decisions in intensive care units (ICUs), different staff groups have different roles in the decision-making process and may not always assess the situation in the same way. The aim of this study was to examine the challenges Danish nurses, intensivists, and primary physicians experience with end-of-life decisions in ICUs and how these challenges affect the decision-making process. Interviews with nurses, intensivists, and primary physicians were conducted, and data is discussed from an ethical perspective. All three groups found that the main challenges were associated with interdisciplinary collaboration and future perspectives for the patient. Most of these challenges were connected with ethical issues. The challenges included different assessments of treatment potential, changes and postponements of withholding and withdrawing therapy orders, how and when to identify patients' wishes, and suffering caused by the treatment. To improve end-of-life decision-making in the ICU, these challenges need to be addressed by interdisciplinary teams.

End-of-life practices in Danish ICUs: development and validation of a questionnaire.

BACKGROUND: Practices for withholding or withdrawing therapy vary according to professional, cultural and religious differences. No Danish-validated questionnaire examining withholding and withdrawing practices exists, thus the aim of this study was to develop and validate a questionnaire for surveying the views of intensive care nurses, intensivists, and primary physicians regarding collaboration and other aspects of withholding and withdrawing therapy in the ICU. METHODS: A questionnaire was developed on the basis of literature, focus group interviews with intensive care nurses and intensivists, and individual interviews with primary physicians. The questionnaire was validated in the following 3 phases: a qualitative test with 17 participants; a quantitative pilot test with 60 participants; and a survey with 776 participants. The validation process included tests for face and content validity (by interviewing participants in the qualitative part of the pilot study), reliability (by assessing the distribution of responses within the individual response categories), agreement (by conducting a test-retest, evaluated by paired analyses), known groups' validity (as a surrogate test for responsiveness, by comparing two ICUs with a known difference in end-of-life practices), floor and ceiling effect, and missing data. RESULTS: Face and content validity were assessed as good by the participants in the qualitative pilot test; all considered the questions relevant and none of the participants found areas lacking. Almost all response categories were used by the participants, thus demonstrating the questionnaires ability to distinguish between different respondents, agreement was fair (the average test-retest agreement for the Likert scale responses was 0.54 (weighted kappa; range, 0.25-0.73), and known groups' validity was proved by finding significant differences in level of satisfaction with interdisciplinary collaboration and in experiences of withdrawal decisions being unnecessarily postponed. Floor and ceiling effect was in accordance with other questionnaires, and missing data was limited to a range of 0-7% for all questions. CONCLUSIONS: The validation showed good and fair areas of validity of the questionnaire. The questionnaire is considered a useful tool to assess the perceptions of collaboration and other aspects of withholding and withdrawing therapy practices in Danish ICUs amongst nurses, intensivists, and primary physicians.

[Insufficient preoperative anaesthesiological assessment of dental status]. / Insufficient præoperativ anæstesiologisk vurdering af tandstatus.

We conducted a comparison of the preoperative airway and teeth status assessment with a dedicated postoperative assessment. We included 211 patients with a preoperative airway and teeth assessment performed by the designated physicians at the department of anaesthesia. 27% of the patients had an incomplete preoperative assessment. 66% were not informed about the risk of damages to the teeth and 16% of the patients were postoperatively considered to have periodontitis compared to only 3% preoperatively. Postoperatively we found, that many more patients had an overall poor dental status.

Withholding or withdrawing therapy in intensive care units: an analysis of collaboration among healthcare professionals.

PURPOSE: The purpose of the study was to determine the views of intensive care nurses, intensivists, and primary physicians regarding collaboration and other aspects of withholding and withdrawing therapy in the intensive care unit (ICU). METHODS: A questionnaire survey was conducted in seven hospitals in the Region of Southern Denmark, including six regional and four university ICUs. Four hundred ninety-five nurses, 135 intensivists, and 146 primary physicians participated in the study. The primary physicians came from two regional hospitals. RESULTS: The unified response rate was 84%. "Futile therapy" and "Patient's wish" were for all participants the main reasons for considering withholding or withdrawing therapy. Of primary physicians 63% found their general experience of collaboration very or extremely satisfactory compared to 36% of intensivists and 27% of nurses. Forty-three percent of nurses, 29% of intensivists, and 2% of primary physicians found that decisions regarding withdrawal of therapy were often, very often, or always unnecessarily postponed. Intensivists with ICU as their main workplace were more satisfied with the collaboration and more rarely found that end-of-life decisions were changed or postponed compared to intensivists who did not have ICU as their main workplace. CONCLUSION: Nurses, intensivists and primary physicians differ in their perception of collaboration and other aspects of withholding and withdrawing therapy practises at the ICU. Multi-disciplinary patient conferences, nurse involvement in the decision-making process, and guidelines for withholding and withdrawing therapy are recommended.

[Treatment of incurable patient in intensive care unit]. / Behandling på intensivafdeling af uhelbredelig syg patient.

This case represents an ethical problem in dealing with patients with prolonged stay of treatment and poor prognosis for survival in the context of known under-capacity in intensive care units (ICUs) in Denmark. A young man, diagnosed with paroxysmal nocturnal haemoglobinuria and myelodysplastic syndrome, developed necrotizing fasciitis and died of sepsis after 42 days. The treatment options were exhausted and treatment was eventually limited to antibiotics and fluid therapy, which raises the question; should ICUs be used for palliative care?

Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial.

OBJECTIVE: To investigate the effect of a restricted intravenous fluid regimen versus a standard regimen on complications after colorectal resection. SUMMARY BACKGROUND DATA: Current fluid administration in major surgery causes a weight increase of 3-6 kg. Complications after colorectal surgery are reported in up to 68% of patients. Associations between postoperative weight gain and poor survival as well as fluid overload and complications have been shown. METHODS: We did a randomized observer-blinded multicenter trial. After informed consent was obtained, 172 patients were allocated to either a restricted or a standard intraoperative and postoperative intravenous fluid regimen. The restricted regimen aimed at maintaining preoperative body weight; the standard regimen resembled everyday practice. The primary outcome measures were complications; the secondary measures were death and adverse effects. RESULTS: The restricted intravenous fluid regimen significantly reduced postoperative complications both by intention-to-treat (33% versus 51%, P = 0.013) and per-protocol (30% versus 56%, P = 0.003) analyses. The numbers of both cardiopulmonary (7% versus 24%, P = 0.007) and tissue-healing complications (16% versus 31%, P = 0.04) were significantly reduced. No patients died in the restricted group compared with 4 deaths in the standard group (0% versus 4.7%, P = 0.12). No harmful adverse effects were observed. CONCLUSION: The restricted perioperative intravenous fluid regimen aiming at unchanged body weight reduces complications after elective colorectal resection.