Abstract
Background
Mortality from critical illness is improving, but survivors suffer from prolonged weakness and psychological and cognitive impairments. Maximising the recovery after critical illness has been highlighted as a research priority, especially in relation to an ageing population who present with higher rates of pre-morbid disability. Small studies have shown that starting rehabilitation early within the intensive care unit (ICU) improves short-term outcomes. Systematic reviews have highlighted the need for robust multicentre randomised controlled trials with longer term follow-up.
Methods
The study design is a randomised controlled study to explore the feasibility of providing earlier and enhanced rehabilitation to mechanically ventilated patients at high risk of ICU-acquired weakness within the ICU. The rehabilitation intervention involves a structured programme, with progression along a functionally based mobility protocol according to set safety criteria. The overall aim of the intervention is to commence mobilisation at an earlier time point in the patient’s illness and increase mobility of the patient through their recovery trajectory. Participants will be randomised to enhanced rehabilitation or standard care, with the aim of recruiting at least 100 patients over 16 months. The trial design will assess recruitment and consent rates from eligible patients, compliance with the intervention, and assess a range of possible outcome measures for use in a definitive trial, with follow-up continuing for 12 months post hospital discharge.
Discussion
This study will evaluate the feasibility of providing an earlier and enhanced rehabilitation intervention to mechanically ventilated patients in critical care. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a phase III multicentre trial of enhanced rehabilitation for critically ill adults.
Trial registration
ISRCTN90103222, 13/08/2015; retrospectively registered.
Mortality from critical illness is improving, but survivors suffer from prolonged weakness and psychological and cognitive impairments. Maximising the recovery after critical illness has been highlighted as a research priority, especially in relation to an ageing population who present with higher rates of pre-morbid disability. Small studies have shown that starting rehabilitation early within the intensive care unit (ICU) improves short-term outcomes. Systematic reviews have highlighted the need for robust multicentre randomised controlled trials with longer term follow-up.
Methods
The study design is a randomised controlled study to explore the feasibility of providing earlier and enhanced rehabilitation to mechanically ventilated patients at high risk of ICU-acquired weakness within the ICU. The rehabilitation intervention involves a structured programme, with progression along a functionally based mobility protocol according to set safety criteria. The overall aim of the intervention is to commence mobilisation at an earlier time point in the patient’s illness and increase mobility of the patient through their recovery trajectory. Participants will be randomised to enhanced rehabilitation or standard care, with the aim of recruiting at least 100 patients over 16 months. The trial design will assess recruitment and consent rates from eligible patients, compliance with the intervention, and assess a range of possible outcome measures for use in a definitive trial, with follow-up continuing for 12 months post hospital discharge.
Discussion
This study will evaluate the feasibility of providing an earlier and enhanced rehabilitation intervention to mechanically ventilated patients in critical care. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a phase III multicentre trial of enhanced rehabilitation for critically ill adults.
Trial registration
ISRCTN90103222, 13/08/2015; retrospectively registered.
| Original language | English |
|---|---|
| Article number | 19 |
| Number of pages | 9 |
| Journal | Pilot and Feasibility Studies |
| Volume | 3 |
| DOIs | |
| Publication status | Published - 17 Apr 2017 |
| Externally published | Yes |
Bibliographical note
Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords
- Critical care
- Mechanical ventilation
- Rehabilitation
- Physiotherapy