Clinical trial NCT04819529: Early and Intensive Occupational Therapy in Mechanical Ventilated Patients
Official title: Early and Intensive Occupational Therapy Improves the Functional Status of Critical Patients Undergoing Mechanical Ventilation at Discharge: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Ventilator Lung
Impairment, Cognitive
Impairment, Coordination
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Hospital Base Valdivia
name: Hospital Santiago Oriente - Dr. Luis Tisné Brousse
First posted: 2021-03-29
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.

Detailed description: A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.

A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early and intensive OT plus ASDM.

The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years.
* Need for hospitalization in ICU.
* At least 12 h of invasive mechanical ventilation
* Informed consent signed by legal representative and / or patient.

Exclusion Criteria:

* Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores\> 3.3 were excluded.
* Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as \> 6 points.
* Severe communication disorder and cultural limitation of language (language different from Spanish)
* Patient with limited therapeutic proportionality.
* Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
* Spinal injury or unstable fractures that limit mobilization

Primary outcomes:
measure: Functional independence at hospital discharge
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary outcomes:
measure: Delirium-free days
timeFrame: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
measure: Coma-free days
timeFrame: Defined as the number of days in the first 14 days with the SAS.
measure: Delirium-coma free days
timeFrame: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
measure: Hazard ratio for delirium in the interventional versus control group
timeFrame: Collecting from the first 14 days with the CAM-ICU instrument and coma.
measure: Cognitive status of patients
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
measure: Motor status of patients
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
measure: Quality of life of patients
timeFrame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
measure: Mental health
timeFrame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
measure: Functional independence
timeFrame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University of Chile
state: Metropolitana
Study officials:
References:
citation: Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care. 2013 Apr 27;17(2):R81. doi: 10.1186/cc12695.
citation: Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
citation: van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Functional status after intensive care: a challenge for rehabilitation professionals to improve outcome. J Rehabil Med. 2009 Apr;41(5):360-6. doi: 10.2340/16501977-0333.
citation: Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
citation: Marra A, Ely EW, Pandharipande PP, Patel MB. The ABCDEF Bundle in Critical Care. Crit Care Clin. 2017 Apr;33(2):225-243. doi: 10.1016/j.ccc.2016.12.005.
citation: Costigan FA, Duffett M, Harris JE, Baptiste S, Kho ME. Occupational Therapy in the ICU: A Scoping Review of 221 Documents. Crit Care Med. 2019 Dec;47(12):e1014-e1021. doi: 10.1097/CCM.0000000000003999.
citation: Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
citation: Sacanella E, Perez-Castejon JM, Nicolas JM, Masanes F, Navarro M, Castro P, Lopez-Soto A. Functional status and quality of life 12 months after discharge from a medical ICU in healthy elderly patients: a prospective observational study. Crit Care. 2011;15(2):R105. doi: 10.1186/cc10121. Epub 2011 Mar 28.
citation: Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.