this study will compare two breathing assisting devices HFNC and NIV in the treatment of acute heart failure patients

A non-inferiority, randomized, controlled trial comparing high flow nasal cannula to non-invasive ventilation in patients with acute cardiogenic pulmonary edema in emergency room - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058352

Enrollment

112

Registered

2023-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Interventions

Intervention1: high flow nasal cannula(HFNC) oxygen therapy: Patients with acute cardiogenic pulmonary edema will be instituted HFNC therapy.The HFNC group will receive therapy starting at a flow rate

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age 18 to 80years, presenting to Emergency department with acute dyspnea, with clinical, radiological and ultrasonography evidence of acute cardiogenic pulmonary edema. 2.The patient must have substantial breathing difficulties that necessitate the use of non-invasive ventilation techniques to provide relief which is assessed by following criteria 2.1 Respiratory rate(RR) >25 breaths/min with signs of respiratory distress such as, use of accessory muscles of respiration 2.2 SpO2 <90% on room air,PaO2/FiO2 <200 with maximum oxygen supplementation by conventional methods.

Exclusion criteria

Exclusion criteria: 1.Patients needing immediate endotracheal intubation due to severe respiratory distress and inability to maintain adequate oxygenation(SpO2 2.Patients with cardiac or respiratory arrest 3.Patients with hemodynamic instability 4.Patients with a low Glasgow Coma Scale score 5.Patients having excessive respiratory secretions 6.Agitated/Non-cooperative patients 7.Patients associated with pulmonary diseases like AECOPD/pneumonia/interstitial lung disease/pneumothorax/lung metastasis/miliary TB 8.Patients with fluid overload due to chronic kidney disease 9.Patients with acute myocardial infarction 10.Patients with do-not-intubate order 11.Patients with home NIV support 12.Pregnant patients

Design outcomes

Primary

Measure	Time frame
Primary outcome:Intubation rate within 72 hours after the initiation of study intervention Indication of Intubation pH less than 7.1 with progressively increasing paCO2, uncontrolled hypoxia defined as paO2 less than 50 despite maximal therapy, serious alterations in consciousness, cardiac arrest or respiratory rate less than 8 or more than 45 per minute or any other life threatening condition.Timepoint: Patient data such as Respiratory rate,Heart rate,SpO2,Blood pressure,Level of dyspnea, B-lines profile on lung ultrasound, arterial blood gas analysis,Ventilator parameters like Oxygen flow(in HFNC),Pressure support and PEEP(in NIV),FiO2 and Tidal Volume to be assessed at 1hour,4 hours,12hours,24 hours,36hours, 48 hours and 72 hours after starting of therapy.	—

Measure

Time frame

Primary outcome:Intubation rate within 72 hours after the initiation of study intervention Indication of Intubation pH less than 7.1 with progressively increasing paCO2, uncontrolled hypoxia defined as paO2 less than 50 despite maximal therapy, serious alterations in consciousness, cardiac arrest or respiratory rate less than 8 or more than 45 per minute or any other life threatening condition.Timepoint: Patient data such as Respiratory rate,Heart rate,SpO2,Blood pressure,Level of dyspnea, B-lines profile on lung ultrasound, arterial blood gas analysis,Ventilator parameters like Oxygen flow(in HFNC),Pressure support and PEEP(in NIV),FiO2 and Tidal Volume to be assessed at 1hour,4 hours,12hours,24 hours,36hours, 48 hours and 72 hours after starting of therapy.

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Secondary

Measure	Time frame
1.Improvement in PaO2,PaCO2,pH,respiratory rate,heart rate. 2.To evaluate patient reported outcomes such as dyspnea,comfort 3.To compare the length of hospital stay & mortality rates in patients treated with HFNC versus NIVTimepoint: 0mins,1hour,4hours,12hours,24hours,48hours,72hours	—

Countries

India

Contacts

Public ContactAmal Ravi

AIIMS Bhubaneswar

tem_sadananda@aiimsbhubaneswar.edu.in07682959066

Outcome results

None listed

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