Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

Critical Illness Clinical Trial

Official title:

Early and Intensive Occupational Therapy Improves the Functional Status of Critical Patients Undergoing Mechanical Ventilation at Discharge: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819529
• Other study ID #: SA19I0138
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2021
• Source: University of Chile
• Contact: Eduardo Tobar, MD
• Phone: +56229786009
• Email: etobar[@]hcuch.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 1, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cognitive Dysfunction
• Critical Illness
• Impairment, Cognitive
• Impairment, Coordination
• Ventilator Lung

Intervention

Behavioral:
• Early and Intensive Occupational Therapy
Occupational therapists will implement the following activities: Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and SAS 2 one session each 24 h. Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5 Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas Education: daily visits by trained family members and health staff about the intervention process

Locations

Country	Name	City	State
Chile	University of Chile	Santiago	Metropolitana

Sponsors (3)

Lead Sponsor	Collaborator
University of Chile	Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse

Country where clinical trial is conducted

Chile, 

References & Publications (9)

Álvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceño CD, González 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. 20 — View 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. Review. — View Citation

Devlin JW, Skrobik Y, Gélinas 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. — View 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. — View 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. Review. — View Citation

Sacanella E, Pérez-Castejón JM, Nicolás JM, Masanés F, Navarro M, Castro P, López-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 — View 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, critic — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional independence at hospital discharge	The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group	Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary	Delirium-free days	CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator	Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Secondary	Coma-free days	SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day	Defined as the number of days in the first 14 days with the SAS.
Secondary	Delirium-coma free days	SAS and CAM-ICU instruments will be applied once a day by evaluator. Every day without coma or delirium its an delirium-coma free day	Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Secondary	Hazard ratio for delirium in the interventional versus control group	A composite analysis who involves delirium-coma free days to day 14. Hazard Ratio <1 interpreted as a lower daily hazard of delirium - implying a shorter mean duration of delirium among days at risk for delirium	Collecting from the first 14 days with the CAM-ICU instrument and coma.
Secondary	Cognitive status of patients	MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group	Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Secondary	Motor status of patients	Grip strength (motor status) with dynamometer will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group	Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary	Quality of life of patients	EQ-5D-5L (Euro Qol 5 dimensions 5 level) will be applied by evaluator. It will be considered a cut-off point in the Chilean population	Day 90 (+/- 7 days) from beginning of mechanical ventilation
Secondary	Mental health	Hospital Anxiety and Depression Scale (HADS) will be applied by evaluator. This scale shows that lower score is better, which will be compared between control and experimental group	Day 90 (+/- 7 days) from beginning of mechanical ventilation
Secondary	Functional independence	The FIM (Functional independence measure) instrument will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group	Day 90 (+/- 7 days) from beginning of mechanical ventilation