Critical CareNCT06133504
Early Multimodal Therapy and Mechanical Ventilation
A study testing Early Multimodal Therapy and Late Multimodal Therapy in people with Critical Care and Critical Illness, run by Fundación Santa Fe de Bogota.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critical Care, Critical Illness
- What is being tested?
- Early Multimodal Therapy and Late Multimodal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Conditions
- Critical Care, Critical Illness
- Being tested
- Early Multimodal Therapy, Late Multimodal Therapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Multimodal TherapyProcedure or surgery
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 TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early arm | Active comparator | Early multimodal therapy is characterized by a comprehensive set of therapeutic interventions executed by the physiotherapy, speech therapy, respiratory therapy, and occupational therapy teams precisely at the moment of study inclusion. This tailored approach ensures that patients receive a coordinated and multidisciplinary therapeutic regimen right from the outset of their participation in the study Receives: Procedure: Early Multimodal Therapy |
| Late arm | Active comparator | While late multimodal therapy is characterized by the same type of maneuvers carried out by the same disciplinary team but initiated once indicated by the attending physician. Receives: Procedure: Late Multimodal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) from intubation to extubation.
Days of mechanical ventilation duration
Measured: 28 days
Secondary outcomes (20)
Ventilator-free days until day 28
28 minus the days of mechanical ventilation
Measured: 28 days
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).
Measured: 28 days
Delirium-free days until day 28
28 minus days with presence of delirium
Measured: 28 days
Sedation days until day 28.
Sedation days until day 28.
Measured: 28 days
Sedation-free days until day 28
28 days minus days of sedation
Measured: 28 days
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.
Measured: 28 days
Hospitalization days
Hospitalization days
Measured: 90 days
ICU length of stay
ICU length of stay
Measured: 28 days
Mortality from any cause up to 90 days
Mortality from any cause up to 90 days
Measured: 90 days
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
Measured: 90 days
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
Measured: 28 days
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
Measured: 28 days
Swallowing difficulty at 72 hours.
Presence of dysphagia at 72 hours after extubation
Measured: 28 days
Time until the initiation of oral intake
Time to initiate oral intake after extubation: 1) 12-24 hours, 2) > 24 hours
Measured: 28 days
Development of healthcare-associated pneumonia
Pneumonia associated with invasive mechanical ventilation. Yes or no.
Measured: 28 days
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.
Measured: 28 days
Grip strength
Grip strength of the dominant hand within 24 hours post-extubation. Kilograms. Score is 0 if the patient deceases
Measured: 28 days
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
Measured: 28 days
Need for non-invasive mechanical ventilation
Need for non-invasive mechanical ventilation: Yes or No
Measured: 28 days
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startJul 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Iván Alvarado, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133504
- Sponsor's protocol ID
- SECEC-2023-129
- Status last verified
- Jul 2025
- First submitted
- 10 Nov 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarado Sanchez JI, Castillo Morales LM, Cardenas Bolivar YR, Montanez Narino V, Stozitzky Rios MV, Arevalo Guerrero CL, Pulido Bobadilla ML, Melo Rojas DM, Lopez Rubio AG, Ortiz Moreno DC, Barreto Garzon PA, Murillo M, Mora-Salamanca AF. Efficacy and safety of the early implementation of a multimodal rehabilitation program in mechanically ventilated patients: A randomized clinical trial protocol. PLoS One. 2025 May 19;20(5):e0324335. doi: 10.1371/journal.pone.0324335. eCollection 2025.
PubMed 40388519
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06133504
- Acronym / sponsor ID
- SECEC-2023-129
- Conditions
- Critical Care, Critical Illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Early arm | Active comparator | Procedure: Early Multimodal TherapyEarly multimodal therapy is characterized by a comprehensive set of therapeutic interventions executed by the physiotherapy, speech therapy, respiratory therapy, and occupational therapy teams precisely at the moment of study inclusion. This tailored approach ensures that patients receive a coordinated and multidisciplinary therapeutic regimen right from the outset of their participation in the study |
| Late arm | Active comparator | Procedure: Late Multimodal TherapyWhile late multimodal therapy is characterized by the same type of maneuvers carried out by the same disciplinary team but initiated once indicated by the attending physician. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Multimodal TherapyEarly 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. | Procedure or surgery | Early arm |
| Late Multimodal TherapyLate 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. | Procedure or surgery | Late arm |
Primary outcome
Time (days) from intubation to extubation.
Time frame: 28 days
Days of mechanical ventilation duration
20 secondary outcomes
Ventilator-free days until day 28
Time frame: 28 days
Delirium days until day 28
Time frame: 28 days
Delirium-free days until day 28
Time frame: 28 days
Sedation days until day 28.
Time frame: 28 days
Sedation-free days until day 28
Time frame: 28 days
Barthel Index at hospital discharge
Time frame: 28 days
Hospitalization days
Time frame: 90 days
ICU length of stay
Time frame: 28 days
Mortality from any cause up to 90 days
Time frame: 90 days
Functional independence status measured by ADLs at hospital discharge
Time frame: 90 days
Functional independence status measured by ADLs at ICU discharge
Time frame: 28 days
Muscle strength measured using the Medical Research Council (MRC) scale
Time frame: 28 days
Swallowing difficulty at 72 hours.
Time frame: 28 days
Time until the initiation of oral intake
Time frame: 28 days
Development of healthcare-associated pneumonia
Time frame: 28 days
Maximum mobility measured by JH-HLM (Johns Hopkins Highest Level of Mobility) scale
Time frame: 28 days
Grip strength
Time frame: 28 days
Extubation failure
Time frame: 28 days
Need for non-invasive mechanical ventilation
Time frame: 28 days
Cognitive function measured using the Montreal Cognitive Assessment (MOCA).
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 40388519Alvarado Sanchez JI, Castillo Morales LM, Cardenas Bolivar YR, Montanez Narino V, Stozitzky Rios MV, Arevalo Guerrero CL, Pulido Bobadilla ML, Melo Rojas DM, Lopez Rubio AG, Ortiz Moreno DC, Barreto Garzon PA, Murillo M, Mora-Salamanca AF. Efficacy and safety of the early implementation of a multimodal rehabilitation program in mechanically ventilated patients: A randomized clinical trial protocol. PLoS One. 2025 May 19;20(5):e0324335. doi: 10.1371/journal.pone.0324335. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Early Multimodal Therapy and Late Multimodal Therapy in people with Critical Care and Critical Illness, run by Fundación Santa Fe de Bogota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Alvarado, MD (3017858459, jialvarados@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (days) from intubation to extubation. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.