Clinical trial NCT06133504: Early Multimodal Therapy and Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Care
Critical Illness
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a phase III randomized clinical trial at a single center with two patient groups, "early arm" (EA) and "late arm," assigned through stratified randomization. Allocation concealment uses sealed envelopes. EA includes intubated patients receiving early multimodal therapy, while the "late arm" starts therapy during ventilatory support weaning. Blinding isn't feasible, but final assessments at 90 days are blinded to intervention groups. Statisticians analyze data blinded. The study is intention-to-treat based, ensuring a comprehensive evaluation of intervention effectiveness
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Time (days) from intubation to extubation.
timeFrame: 28 days
Secondary outcomes:
measure: Ventilator-free days until day 28
timeFrame: 28 days
measure: Delirium days until day 28
timeFrame: 28 days
measure: Delirium-free days until day 28
timeFrame: 28 days
measure: Sedation days until day 28.
timeFrame: 28 days
measure: Sedation-free days until day 28
timeFrame: 28 days
measure: Barthel Index at hospital discharge
timeFrame: 90 days
measure: Hospitalization days
timeFrame: 90 days
measure: ICU length of stay
timeFrame: 28 days
measure: Mortality from any cause up to 90 days
timeFrame: 90 days
measure: Functional independence status measured by ADLs at hospital discharge
timeFrame: 90 days
measure: Functional independence status measured by ADLs at ICU discharge
timeFrame: 28 days
measure: Muscle strength measured using the Medical Research Council (MRC) scale
timeFrame: 28 days
measure: Swallowing difficulty at 72 hours.
timeFrame: 28 days
measure: Time until the initiation of oral intake
timeFrame: 28 days
measure: Development of healthcare-associated pneumonia
timeFrame: 28 days
measure: Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale
timeFrame: 28 days
measure: Grip strength
timeFrame: 28 days
measure: Extubation failure
timeFrame: 28 days
measure: Need for non-invasive mechanical ventilation
timeFrame: 28 days
measure: Cognitive function measured using the Montreal Cognitive Assessment (MOCA).
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: