Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial.

Purpose: Critical illness impairs physical function. The NONSEDA trial was a multicenter randomized trial, assessing non-sedation versus sedation during mechanical ventilation. The aim of this sub-study was to assess the effect of non-sedation on physical function.

Methods: All patients from one NONSEDA trial site were included. At ICU discharge and three months thereafter, survivors were assessed for physical function.

Results: 205 patients were included, 118 survived to follow-up, 116 participated (98%).

Primary Outcome: Three months after ICU-discharge, health-related quality of life (SF-36, physical component score) was similar (non-sedated 38.3 vs sedated 36.6, mean difference 1.7, 95% CI -1.7 to 5.1), as was function in activities of daily living (Barthel Index, non-sedated 19.5 vs sedated 18, median difference 1.5, 95% CI -0.2 to 3.2).

Secondary Outcomes: Non-sedated patients had a better Barthel Index at ICU-discharge (median 9 vs 4, median difference 5, 95% CI 2.5 to 7.5). At three months post-ICU discharge, the two groups did not differ regarding handgrip strength, walking distance, muscle size or biomechanical data.

Conclusion: Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living. Non-sedated patients had a better physical recovery at ICU discharge.

Trial Registration: Clinicaltrials.govNCT02034942, registered January 14., 2014.