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

Phase 4

Not yet recruiting

Conditions: Combined systolic (congestive) anddiastolic (congestive) heart failure,

Registration Number: CTRI/2023/10/058352

Lead Sponsor: AIIMS BHUBANESWAR

Brief Summary: Both non invasive ventilation(NIV and High flow nasal cannula(HFNC))have been found to improve oxygenation, decrease work of breathing and improve ventilation in acute pulmonary edema patients. As compared to conventional therapy, there is no head-to-head trial comparing HFNC and NIV therapy in acute cardiogenic pulmonary edema patients.So this study will show whether HFNC is equally efficacious to NIV or not.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 112

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

1.Patients needing immediate endotracheal intubation due to severe respiratory distress and inability to maintain adequate oxygenation(SpO2<90% with oxygen supplementation) 2.Patients with cardiac or respiratory arrest 3.Patients with hemodynamic instability 4.Patients with a low Glasgow Coma Scale score <10 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome:Intubation rate within 72 hours after the initiation of study intervention	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.
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.	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.
Indication of Intubation	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.

Secondary Outcome Measures

Name	Time	Method
1.Improvement in PaO2,PaCO2,pH,respiratory rate,heart rate.	2.To evaluate patient reported outcomes such as dyspnea,comfort

Trial Locations

Locations (1): AIIMS BHUBANESWAR
🇮🇳
Khordha, ORISSA, India
AIIMS BHUBANESWAR
🇮🇳Khordha, ORISSA, India
Dr Sadananda Barik
Principal investigator
7682959066
tem_sadananda@aiimsbhubaneswar.edu.in