Early Multimodal Therapy and Mechanical Ventilation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFundación Santa Fe de Bogota

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Multimodal Therapy

    Procedure/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 Therapy

    Procedure/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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Early armActive comparator 1 intervention
Group B: Late armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time (days) from intubation to extubation.

Days of mechanical ventilation duration

Time frame
28 days

Secondary outcomes

1

Ventilator-free days until day 28

28 minus the days of mechanical ventilation

Time frame
28 days
2

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).

Time frame
28 days
3

Delirium-free days until day 28

28 minus days with presence of delirium

Time frame
28 days
4

Sedation days until day 28.

Sedation days until day 28.

Time frame
28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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