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NCT Number: NCT06133504

Early Multimodal Therapy and Mechanical Ventilation

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.

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Key information

Conditions

Critical Care Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Invasive mechanical ventilation through tracheostomy or a nasotracheal tube.
  • History of head and neck surgery at any time prior to ICU admission.
  • Patients directly admitted to the ICU due to cardiac arrest by any cause.
  • Airway burn.
  • Burns involving ≥ 50% of the body surface area.
  • Chronic obstructive pulmonary disease (these patients usually require prolonged mechanical ventilation due to the underlying respiratory dysfunction)
  • Patients referred from another institution.
  • Demyelinating diseases or neuromuscular junction disorders at ICU admission.
  • Patients requiring neuromuscular blockade.
  • Patients with a life expectancy of ≤180 days will be excluded based on their primary diagnosis (e.g., advanced cancer, end-stage heart failure), comorbidities, recent clinical course, medical judgment by the ICU team, and functional status as assessed by the Barthel index.
  • ICU readmissions.
  • Participation in other rehabilitation clinical trials.
  • Liver or kidney transplant.
  • Patients with an active cancer diagnosis undergoing oncological treatment (chemotherapy/surgery) at the time of eligibil- ity assessment.

Treatment and study plan

Early Multimodal Therapy

Procedure

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

Procedure

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.

Primary outcomes

  1. Time (days) from intubation to extubation.

    Time frame: 28 days

    Days of mechanical ventilation duration

Secondary outcomes

  1. Ventilator-free days until day 28

    Time frame: 28 days

    28 minus the days of mechanical ventilation

  2. Delirium days until day 28

    Time frame: 28 days

    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).

  3. Delirium-free days until day 28

    Time frame: 28 days

    28 minus days with presence of delirium

  4. Sedation days until day 28.

    Time frame: 28 days

    Sedation days until day 28.

  5. Sedation-free days until day 28

    Time frame: 28 days

    28 days minus days of sedation

  6. Barthel Index at hospital discharge

    Time frame: 28 days

    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.

  7. Hospitalization days

    Time frame: 90 days

    Hospitalization days

  8. ICU length of stay

    Time frame: 28 days

    ICU length of stay

  9. Mortality from any cause up to 90 days

    Time frame: 90 days

    Mortality from any cause up to 90 days

  10. Functional independence status measured by ADLs at hospital discharge

    Time frame: 90 days

    Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom

  11. Functional independence status measured by ADLs at ICU discharge

    Time frame: 28 days

    Activities of Daily Living (ADLs), each variable scores one point: bathing, dressing, eating, grooming, transferring from bed to chair, and using the bathroom

  12. Muscle strength measured using the Medical Research Council (MRC) scale

    Time frame: 28 days

    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

  13. Swallowing difficulty at 72 hours.

    Time frame: 28 days

    Presence of dysphagia at 72 hours after extubation

  14. Time until the initiation of oral intake

    Time frame: 28 days

    Time to initiate oral intake after extubation: 1) 12-24 hours, 2) > 24 hours

  15. Development of healthcare-associated pneumonia

    Time frame: 28 days

    Pneumonia associated with invasive mechanical ventilation. Yes or no.

  16. Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale

    Time frame: 28 days

    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.

  17. Grip strength

    Time frame: 28 days

    Grip strength of the dominant hand within 24 hours post-extubation. Kilograms. Score is 0 if the patient deceases

  18. Extubation failure

    Time frame: 28 days

    Inability to breathe spontaneously in the first 48 hours after removal of artificial airway, and the patient is unable to maintain a patent airway

  19. Need for non-invasive mechanical ventilation

    Time frame: 28 days

    Need for non-invasive mechanical ventilation: Yes or No

  20. Cognitive function measured using the Montreal Cognitive Assessment (MOCA).

    Time frame: 90 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Alvarado, MD

CONTACT

[email protected]

3017858459

Sponsors and collaborators

Lead sponsor

Fundación Santa Fe de Bogota

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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