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This single-center observational study aims to explore the relationship between the CPAx score (Chelsea Critical Care Physical Assessment Tool), measured at ICU discharge, and the 6-minute walk test (6MWT) distance performed 3 months after discharge. The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness, or post-traumatic stress symptoms. Data collection includes the CPAx score, 6MWT distance, MRC score, and relevant clinical and demographic information. The primary objective is to determine whether the CPAx score can predict long-term functional recovery and guide post-ICU rehabilitation strategies. Participants will be evaluated during routine follow-up in the day hospital. This non-interventional study poses minimal risk to participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAx | Diagnostic Test | Evaluation of : Respiratory function Cough Moving within the bed Supine to sitting on the edge of the bed Dynamic sitting Standing balance Sit to stand (starting position ≥ 90°) Transfering from bed to chair Stepping Grip strength (predicted mean for age and gender on the strongest hand) |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive validity beetween CPAx test and 6MWT | Evaluation Criteria: The statistical analysis will primarily aim to assess the correlation between the CPAx score, a discrete quantitative variable (ranging from 0 to 50), and the distance covered in the 6-Minute Walk Test (6MWT), a continuous quantitative variable. The alpha risk is set at 5% and the beta risk at 80%. A sample size of 25 patients has been determined to allow for an initial estimate, accounting for an anticipated 20% loss to follow-up, in line with recommendations for feasibility studies in intensive care settings. Method : The choice of correlation test will depend on data distribution:
| Three months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between CPAx and SF-36 questionnary | Analysis of the correlation between each item of the CPAx and the results of the 6-minute walk test three months after ICU discharge. Analysis of the correlation between individual CPAx item scores and SF-36 questionnaire results three months after ICU discharge Methods for Secondary Outcomes:
Exploratory analyses using simple or multiple linear regression may also be conducted to model the relationship between CPAx and 6MWT, adjusting for clinical variables (age, BMI, duration of ventilation, etc.). |
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Inclusion Criteria:
Patient affiliated with, or entitled to benefit from, a French social security system.
Patient who has received clear and comprehensive information about the study and has signed the informed consent form together with the investigator.
Age ≥ 18 years.
Having received at least 48 hours of invasive mechanical ventilation.
Previous hospitalization in the intensive care unit (ICU) at CHI Elbeuf-Louviers-Val-de-Reuil.
Prescription of physiotherapy during the ICU stay.
Eligible for the 3-month post-ICU follow-up in the day hospital based on at least one of the following criteria:
Ability to walk (with or without assistive devices) prior to ICU admission.
Exclusion Criteria:
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The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness (icuaw), or post-traumatic stress symptoms
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur SAUNIER, MKDE | Contact | 0232962296 | arthur.saunier@chi-elbeuf-louviers.fr | |
| Pierre HUNKELER | Contact | 0232963439 | pierre.hunkeler@chi-elbeuf-louviers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil | Recruiting | Saint-Aubin-lès-Elbeuf | 76410 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24669784 | Result | Corner EJ, Soni N, Handy JM, Brett SJ. Construct validity of the Chelsea critical care physical assessment tool: an observational study of recovery from critical illness. Crit Care. 2014 Mar 27;18(2):R55. doi: 10.1186/cc13801. | |
| 27259819 | Result | Skinner EH, Thomas P, Reeve JC, Patman S. Minimum standards of clinical practice for physiotherapists working in critical care settings in Australia and New Zealand: A modified Delphi technique. Physiother Theory Pract. 2016 Aug;32(6):468-482. doi: 10.3109/09593985.2016.1145311. Epub 2016 Jun 3. |
| Label | URL |
|---|---|
| Rehabilitation after critical illness in adults (Clinical guideline \[CG83\]) | View source |
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|
| Three months after discharge |
| 23219649 | Result | Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30. |
| 17855814 | Result | De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8. |
| 18511703 | Result | Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29. |
| 12472328 | Result | De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859. |
| 12594312 | Result | Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450. |
| 21939902 | Result | Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8. |
| 27864615 | Result | Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18. |
| Diagnostic et prise en charge des patients adultes avec un syndrome post-réanimation (PICS) et de leur entourage | View source |