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Evaluation of High Flow Nasal Cannula Weaning Strategies

Comparing efficacy of three strategies for weaning of High Flow Nasal Cannula in critically ill patients with Acute Hypoxemic Respiratory Failure: Exploratory Randomized Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061737
Enrollment
100
Registered
2024-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: J962- Acute and chronic respiratory failure

Interventions

Intervention1: Group A with Flow reduction strategy.: In Group A with Flow reduction strategy, flow will be gradually reduced by 10 L/min/hr. When it reaches 20 L/min, FiO2 reduction will then begin a

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients on HFNC for AHRF and satisfying all of the following weaning criteria: 1. Age more than 18 years 2. No signs of respiratory distress (increased work of breathing, use of accessory muscles of respiration leading to diaphoresis, anxiety or agitation) 3. Arterial pH more than or equal to 7.35, SpO2 more than 90% on FiO2 less than or equal to 0.6 4. Respiratory rate less than 25/min, Heart rate less than 120/min, Systolic blood pressure more than or equal to 90 mmHg.

Exclusion criteria

Exclusion criteria: 1. Respiratory failure requiring or receiving endotracheal intubation or IMV during the current hospital stay. 2. Cardiac arrest, Acute Coronary Syndrome or life-threatening arrhythmias 3. More than or equal to 2 end organ failure other than respiratory failure defined as acute change in total SOFA score more than or equal to 2 points. 4. Patients with recent trauma or burns to the neck and face 5. Hypercapneic respiratory failure (pH less than 7.35 and PaCO2 more than 45)

Design outcomes

Primary

MeasureTime frame
Comparison of success rates of three weaning strategies (Flow reduction vs FiO2 reduction vs simultaneous reduction of flow and FiO2) by Chi-square test.Timepoint: Comparison of success rates of three weaning strategies by Chi-square test. Timeline : From start of weaning from HFNC till 48 hours off HFNC on conventional oxygen therapy via facemask/nasal cannula.

Secondary

MeasureTime frame
Analysis of patient comfort amongst three groups by comparison of mean comfort scores among three weaning strategies (Flow reduction vs FiO2 reduction vs simultaneous reduction of flow and FiO2) using one-way ANOVATimepoint: Time from weaning initiation to withdrawal of HFNC therapy.;Comparison of the average time taken to wean off high flow nasal cannula in the three weaning strategies (Flow reduction vs FiO2 reduction vs simultaneous reduction of flow and FiO2) using one-way ANOVATimepoint: Time from weaning initiation to withdrawal of HFNC therapy.;To compare the proportions of various adverse events amongst the three weaning strategies (Flow reduction vs FiO2 reduction vs simultaneous reduction of flow and FiO2) using Chi-square test.Timepoint: Time from weaning initiation to withdrawal of HFNC therapy.

Countries

India

Contacts

Public ContactDr. Deepansh Gupta

AIIMS, Rishikesh

drprakhar2009@gmail.com0112462984

Outcome results

None listed

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