Early Multimodal Therapy and Mechanical Ventilation

Critical Illness Clinical Trial

Official title:

Association Between Early Multimodal Therapy and Mechanical Ventilation Days in the Intensive Care Unit at Fundación Santa Fe de Bogotá: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133504
• Other study ID #: SECEC-2023-129
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Fundación Santa Fe de Bogota
• Contact: Jorge Alvarado, MD
• Phone: 3017858459
• Email: jialvarados[@]unal.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.

Description:

This study compares the impact of early multimodal therapy on mechanical ventilation duration in ICU patients. It is an open-label, randomized controlled clinical trial. Patients will be assigned to either early multimodal therapy or standard therapy (control) in a 1:1 ratio. Blinding is not possible due to the study design. The analysis will follow an intention-to-treat approach. The hypothesis is that early multimodal therapy reduces mechanical ventilation duration

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

The inclusion criteria are as follows:

Patients hospitalized in the adult intensive care unit of the Fundación Santa Fe de Bogotá. Requirement of invasive mechanical ventilation through an endotracheal tube for a period exceeding 72 hours with an expected continuation of at least 24 hours. Barthel Index equal to or greater than 70 Exclusion Criteria:

Exclusion criteria:

• Patients requiring invasive mechanical ventilation through a tracheostomy tube or nasotracheal tube.
• Patients who have undergone any type of head and neck surgery.
• Cardiac arrest.
• Airway burn.
• Burns with an extent greater than 50% of the body surface area.
• Patients with chronic obstructive pulmonary disease.
• Patients referred from another institution.
• Demyelinating or neuromuscular junction diseases.
• Patients requiring neuromuscular blockade.
• Patients with a life expectancy of less than 180 days.
• Patients deemed by medical criteria not to benefit from multimodal treatment.
• Patients not entering the ICU for the first time.
• Patients participating in other clinical rehabilitation trials

Related Conditions & MeSH terms

• Critical Care
• Critical Illness

Intervention

Procedure:
• Early Multimodal Therapy
Early multimodal therapy is defined as the collection of therapeutic maneuvers performed by the physiotherapy, speech therapy, respiratory therapy, and occupational therapy team at the time of study inclusion.
• Late Multimodal Therapy
Late multimodal therapy is characterized by the same set of maneuvers carried out by the same disciplinary team, but it is initiated once indicated by the attending physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) from intubation to extubation.	Days of mechanical ventilation duration	28 days
Secondary	Ventilator-free days until day 28	28 minus the days of mechanical ventilation	28 days
Secondary	Delirium days until day 28	In order for a patient to be considered to have delirium according to the CAM-ICU, the first criterion (acute change in mental status) must be present, along with at least one of the other three criteria (inability to maintain sustained attention, disorganized thinking, or fluctuating levels of consciousness).	28 days
Secondary	Delirium-free days until day 28	28 minus days with presence of delirium	28 days
Secondary	Sedation days until day 28.	Sedation days until day 28.	28 days
Secondary	Sedation-free days until day 28	28 days minus days of sedation	28 days
Secondary	Barthel Index at hospital discharge	The Barthel Index is a scale used to measure the degree of functional independence in activities of daily living (ADLs) for an individual. The score is 0 if the patient deceases.	90 days
Secondary	Hospitalization days	Hospitalization days	90 days
Secondary	ICU length of stay	ICU length of stay	28 days
Secondary	Mortality from any cause up to 90 days	Mortality from any cause up to 90 days	90 days
Secondary	Functional independence status measured by ADLs at hospital discharge	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom	90 days
Secondary	Functional independence status measured by ADLs at ICU discharge	Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom	28 days
Secondary	Muscle strength measured using the Medical Research Council (MRC) scale	Muscle strength assessment in critical care patients using the Medical Research Council (MRC) scale: 5: Normal - Full range of motion against total resistance 4+: Good (+) - Full range of motion against gravity and strong resistance 4: Good (-) - Full range of motion against gravity and minimal resistance 3+: Fair (+) - Full range of motion against gravity only 3: Fair (-) - Partial range of motion against gravity 2: Poor - Movement with gravity eliminated; 1: Minimal - Visible muscle contraction without movement 0: Absent - Total paralysis	28 days
Secondary	Swallowing difficulty at 72 hours.	Presence of dysphagia at 72 hours after extubation	28 days
Secondary	Time until the initiation of oral intake	Time to initiate oral intake after extubation: 1) 12-24 hours, 2) > 24 hours	28 days
Secondary	Development of healthcare-associated pneumonia	Pneumonia associated with invasive mechanical ventilation. Yes or no.	28 days
Secondary	Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale	Mobility assessment using the JH-HLM (Johns Hopkins Highest Level of Mobility) scale: 8: Walks more than 250 feet. 7: Walks more than 25 feet. 6: Walks more than 10 steps. 5: Stands for more than one minute. 4: Can move to the chair. 3: Can sit on the edge of the bed. 2: Can turn in bed.; 1: Can only lie down. Score is 0 if the patient deceases.	28 days
Secondary	Grip strength	Grip strength of the dominant hand within 24 hours post-extubation. Kilograms. Score is 0 if the patient deceases	28 days
Secondary	Extubation failure	Inability to breathe spontaneously in the first 48 hours after removal of artificial airway, and the patient is unable to maintain a patent airway	28 days
Secondary	Need for non-invasive mechanical ventilation	Need for non-invasive mechanical ventilation: Yes or No	28 days
Secondary	Cognitive function measured using the Montreal Cognitive Assessment (MOCA).	The variable is the cognitive function, assessed using the Montreal Cognitive Assessment (MOCA). This tool measures various cognitive domains, providing insight into an individual's cognitive abilities and identifying potential cognitive impairment	90 days