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Clinical Trials/CTRI/2024/05/067659
CTRI/2024/05/067659
Not yet recruiting
Not Applicable

Highflow nasal cannula versus noninvasive ventilation in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure. A Randomised Comparative Interventional Study at SMS Medical College

Department of Anaesthesiology SMS Medical College1 site in 1 country80 target enrollmentStarted: June 23, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of Anaesthesiology SMS Medical College
Enrollment
80
Locations
1
Primary Endpoint
To Assess Need for Invasive Mechanical Ventilation In Patients of Acute Hypoxemic Respiratory Failure.

Overview

Brief Summary

Patients with AHRF will be admitted to ICU.

Sample of patients satisfying the inclusion criteria will be selected for study and patients will be randomized into two groups by computer random number table method.

Patients will be assigned to NIV or HFNC.

Patient assigned NIV will be connected to ventilator for conventional NIV with full mask with following ventilator settings with PEEP 2 to 10 cm of water initially later PEEP or FiO2 or both will be set to keep SaO2≥92%. Ps level will be set to achieve expiratory tidal volume of 7 to 10 ml/kg.

Patient of other group will be connected to HFNC and heated humidified oxygen 31-37 C will be continuously supplied through binasal large bore prongs. Initial setting of oxygen flow rate will be 50L/min and FiO21.0, later setting of Fio2will be adjusted to attain SaO2≥92%

Following parameter will be recorded in both groups

  1. Total number of patients in percentage will be required need of intubation due to following reasons

pH < 7.20

paO2 <45mmHg

paCO2 >60mmHg

Cardiopulmonary arrest

  1. To Measure Vital parameters (SBP, DBP, MAP, HR, RR, SPO2) at inclusion and at 12, 24, 36, 48, 60, 72 hours.

  2. To Assess Respiratory Acidosis by recording ABG at 1, 6, 24, 48 hours of study treatment.

  3. To Assess no. of days on HFNC/NIV before escalation to intubation.

  4. To Assess no. of duration of ICU stay.

  5. To Measure Hospital Mortality.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Double

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient willing to give consent Patients having AHRF defined by PaO2/FiO2 less than or equal to 300mmhg Patient not responding to conventional oxygen therapy Patient requiring ventilator support due to increased respiratory rate.

Exclusion Criteria

  • Absolute indication for intubation Contraindication to NIV PaCO2 more than 45mmhg Chronic respiratory failure.

Outcomes

Primary Outcomes

To Assess Need for Invasive Mechanical Ventilation In Patients of Acute Hypoxemic Respiratory Failure.

Time Frame: until Invasive Mechanical Ventilation

Secondary Outcomes

  • 1.To measure vital parameters (SBP, DBP, MAP, HR, RR, SPO2)(2.To assess respiratory acidosis by recording ABG.)

Investigators

Sponsor
Department of Anaesthesiology SMS Medical College
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Nihar Sharma

Sms medical college

Study Sites (1)

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