Hanne T Olsen1,2, Helene K Nedergaard3,2, Catherine L Hough4, Serkan Korkmaz5, Hanne I Jensen3,6, Thomas Strøm7,8,2, Palle Toft7,2. 1. Department of Anesthesiology and Intensive Care, Odense University Hospital, Svendborg Hospital, Baagoes Allé 15, 5700, Svendborg, Denmark. 2. Department of Clinical Research, University of Southern Denmark, J.B. Winsloews Vej 19, 5000, Odense, Denmark. 3. Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Sygehusvej 24, 6000, Kolding, Denmark. 4. Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA. 5. Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark. 6. Department of Regional Health Research, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark. 7. Department of Anesthesiology and Intensive Care, Odense University Hospital, J.B. Winsloews Vej 4, DK - 5000, Odense C, Denmark. 8. Department of Anesthesia & Critical Care Medicine, Hospital Soenderjylland, University of Southern, Denmark.
Abstract
BACKGROUND: Critical illness is associated with severely impaired health related quality of life (HRQoL) for years following discharge. The NONSEDA-trial was a multicenter randomized trial on non-sedation versus sedation with a daily wake-up trial in critically ill, mechanically ventilated patients in Scandinavia. The aim of this sub-study was to assess the effect of non-sedation on HRQoL and degree of independence in activities in daily living (ADL) three months post-ICU. METHODS: All survivors were asked to complete the Medical Outcomes Study Short-Form 36 questionnaire (SF-36) and the Barthel Index three months post-ICU. To limit missing data, reminders were sent. If unsuccessful, telephone interviews could be used. Outcomes were the level of HRQoL and ADL-function in each group. All outcomes were assessed blinded. RESULTS: Of the 700 patients included 412 survived to follow-up. A total of 344 survivors participated (82%). Baseline data were equal between the two groups. Mean SF-36 scores for the non-sedated vs sedated patients were: Physical Function 45 vs 40, p=0.69, Bodily Pain: 61 vs 52, p=0.81, General Health: 50 vs 50, p=0.84, Vitality: 42 vs 44, p=0.85, Social Function: 75 vs 63, p=0.85, Role Emotional: 58 vs 50, p=0.82, Mental Health: 70 vs 70, p=0.89, Role Physical: 25 vs 28, p = 0.32, Physical Component Score: 38 vs 37, p=0.81, Mental Component Score: 48 vs 46, p=0.94, Barthel Index: 20 vs 20, p=0.74. CONCLUSION: Randomization to non-sedation neither improved nor impaired health-related quality of life or degree of independence in activities in daily living three months post ICU-discharge. This article is protected by copyright. All rights reserved.
RCT Entities:
BACKGROUND:Critical illness is associated with severely impaired health related quality of life (HRQoL) for years following discharge. The NONSEDA-trial was a multicenter randomized trial on non-sedation versus sedation with a daily wake-up trial in critically ill, mechanically ventilated patients in Scandinavia. The aim of this sub-study was to assess the effect of non-sedation on HRQoL and degree of independence in activities in daily living (ADL) three months post-ICU. METHODS: All survivors were asked to complete the Medical Outcomes Study Short-Form 36 questionnaire (SF-36) and the Barthel Index three months post-ICU. To limit missing data, reminders were sent. If unsuccessful, telephone interviews could be used. Outcomes were the level of HRQoL and ADL-function in each group. All outcomes were assessed blinded. RESULTS: Of the 700 patients included 412 survived to follow-up. A total of 344 survivors participated (82%). Baseline data were equal between the two groups. Mean SF-36 scores for the non-sedated vs sedated patients were: Physical Function 45 vs 40, p=0.69, Bodily Pain: 61 vs 52, p=0.81, General Health: 50 vs 50, p=0.84, Vitality: 42 vs 44, p=0.85, Social Function: 75 vs 63, p=0.85, Role Emotional: 58 vs 50, p=0.82, Mental Health: 70 vs 70, p=0.89, Role Physical: 25 vs 28, p = 0.32, Physical Component Score: 38 vs 37, p=0.81, Mental Component Score: 48 vs 46, p=0.94, Barthel Index: 20 vs 20, p=0.74. CONCLUSION: Randomization to non-sedation neither improved nor impaired health-related quality of life or degree of independence in activities in daily living three months post ICU-discharge. This article is protected by copyright. All rights reserved.
Entities:
Keywords:
Intensive care; health related quality of life; mechanical ventilation; non-sedation