Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

NCT04819529 | Unknown DMC

• 1 other identifier: SA19I0138
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Ventilator Lung; Impairment, Cognitive; Impairment, Coordination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Delirium-free days

  Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.

• Coma-free days

  Defined as the number of days in the first 14 days with the SAS.

• Delirium-coma free days

  Defined as the number of days in the first 14 days with the SAS and CAM-ICU

• Hazard ratio for delirium in the interventional versus control group

  Collecting from the first 14 days with the CAM-ICU instrument and coma.

• Cognitive status of patients

  Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge

Study Arms (2)

Experimental Group - Early and intensive Occupational Therapy

EXPERIMENTAL

These sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h

Behavioral: Early and Intensive Occupational Therapy

Control group - Standard Analgesia,Sedation, Delirium and Mobilization (ASDM) Protocol

NO INTERVENTION

The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement.

Interventions

Early and Intensive Occupational Therapy BEHAVIORAL

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

Experimental Group - Early and intensive Occupational Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Hospital Base Valdivia: collaborator
• Hospital Santiago Oriente - Dr. Luis Tisné Brousse: collaborator

Study Sites (1)

University of Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (10)

• 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.

  PMID: 23622086 BACKGROUND

• 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.

  PMID: 24638143 BACKGROUND

• 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.

  PMID: 19363570 BACKGROUND

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 28284292 BACKGROUND

• 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.

  PMID: 31738741 BACKGROUND

• 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.

  PMID: 19446324 RESULT

• 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.

  PMID: 21443796 RESULT

• 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.

  PMID: 27660922 RESULT

• Alvarez E, Garrido M, Salech F, Rojas V, Jara N, Farias JI, Ponce D, Tobar E. Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol. Br J Occup Ther. 2023 Nov;86(11):728-739. doi: 10.1177/03080226231184992. Epub 2023 Jul 14.

  PMID: 40336796 DERIVED

MeSH Terms

Conditions

Critical Illness; Cognitive Dysfunction; Ataxia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Eduardo Tobar, MD

CONTACT

+56229786009; etobar@hcuch.cl

Evelyn Alvarez, Master

CONTACT

+56229786009; evalvarez@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, researchers, recruiters, evaluators, control group team and data analyst will be masked. These teams will not have contact with the interventionists of the experimental group. Evaluators who have contact with the patients of both groups, they will be professionals from other medical units, who do not know the ICU team, and will only be able to maintain their dialog, according to the guideline of each evaluation. It is not possible to mask the treating occupational therapist and patient receiving OT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: 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

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 29, 2021
• Study Start: January 20, 2021
• Primary Completion: July 20, 2022
• Study Completion: December 1, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)