Skip to content

Among critically ill patients who requires mechanical ventilation, a study to compare whether giving fluids before insertion of the tube into the windpipe or administering medication after place of the tube prevents sudden drop in blood pressure.

Effect of a FLUid Bolus or a low dose VAsopressor infusion on cardiovascular collapse among critically ill adults undergoing tracheal intubation: a randomized controlled trial(FLUVA Study) - FLUVA Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043925
Enrollment
200
Registered
2022-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures Health Condition 2: J969- Respiratory failure, unspecified

Interventions

Intervention1: Arm Vasopressor (VP): Patients in this group will receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation Control Inte

Sponsors

Tata Memorial Hospital
Lead Sponsor
Not Any
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (>= 18 years old) 2. Critically ill patients needing emergent tracheal intubation in ICU

Exclusion criteria

Exclusion criteria: 1.Tracheal intubation performed in the out-of-ICU/hospital setting 2.Tracheal intubation during cardiac arrest. 3.Patients with age 4.Elective tracheal intubation(for e.g for diagnostic/surgical procedures) 5.Patients on vasoactive medications at the time of screening 6.Hypotension (SBP 7.Hypertension(SBP >140)at screening 8.Urgency of tracheal intubation precludes performance of study procedures 9.Operator feels administration of a fluid bolus vasopressor is strongly indicated or contraindicated 10.Inability to obtain consent from the surrogate

Design outcomes

Primary

MeasureTime frame
Cardiovascular collapse define by 1. decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg, 2.cariac arrest between induction, 3.Death between induction and 1 hour after tracheal intubation Timepoint: at 5 min and 1hrs after tracheal intubation

Secondary

MeasureTime frame
Clinical outcomes define by SBP less than 90 mm Hg or a MAP to less than 65 mm Hg, Cardiac arrest, Death, Lowest SBP, Ventilator-free days, ICU-free days, Vasopressor free days, Need for Renal Replacement therapy, ICU Mortality, Hospital Mortality, 28 Day Mortality Timepoint: at 5 min, 24 hrs and day 28 after intubation;Process measures define as Initiation of an intravenous fluid boluses, Need for vasopressors, Time for successful tracheal intubation, Incidence of successful tracheal intubation on the first laryngoscopy attempt, Number of laryngoscopy attempts, Cormack-Lehane grade of glottic view on first attempt, Need for additional airway equipment or a second operator Timepoint: at 5 min, 24 hrs and day 28 after intubation;Safety outcomes define by Lowest arterial oxygen saturation, Incidence of hypoxaemia (oxygen saturation 90%), Incidence of severe hypoxaemia (oxygen saturation 80%), Incidence of hypertension (SBP 140), Oxygen saturation, Fraction of inspired oxygen, Pao2 /FiO2 ratio Timepoint: at 5 min, 24 hrs and day 28 after intubation

Countries

India

Contacts

Public ContactDr Sheila N Myatra

Tata Memorial Hospital

sheila150@hotmail.com9820156070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026