Status:
ACTIVE_NOT_RECRUITING
Effect of a FLUid Bolus or a Low Dose VAsopressor Infusion on Cardiovascular Collapse Among Critically Ill Adults Undergoing Tracheal Intubation.
Lead Sponsor:
Tata Memorial Centre
Conditions:
Critically Ill Adults in the ICU, Requiring Endotracheal Intubation
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Tracheal intubation, which is one of the most commonly performed procedures in the care of critically ill patients in intensive care unit, is associated with a high incidence of complications. Approxi...
Detailed Description
OBJECTIVES: Primary Objective: Cardiovascular collapse - a composite endpoint defined as one or more of the following: Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease ...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old)
- Critically ill patients needing emergent tracheal intubation in ICU
Exclusion
- Tracheal intubation performed in the out-of-ICU/hospital setting
- Tracheal intubation during cardiac arrest.
- Patients with age \<18 years
- Elective tracheal intubation(for e.g for diagnostic/surgical procedures)
- Patients on vasoactive medications at the time of screening
- Hypotension (SBP \<90) at screening
- Hypertension(SBP \>140)at screening
- Urgency of tracheal intubation precludes performance of study procedures
- Operator feels administration of a fluid bolus vasopressor is strongly indicated or contraindicated
- Inability to obtain consent from the surrogate
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05318066
Start Date
July 15 2022
End Date
March 1 2025
Last Update
January 17 2025
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012