High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

Not Applicable

• Conditions: Acute Respiratory Failure With Hypercapnia

• Registration Number: NCT03229460
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.

Detailed Description

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-23
• Study First Posted: 2017-07-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05
• Study Start: 2019-08
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Hypoxemic and no hypercapnic acute respiratory failure :
• severe dyspnea at rest with a respiratory rate >25 breaths/min
• PaO2/FiO2 <300
• PaCO2 <45 mmHg,

Exclusion Criteria

• age <18 years
• NPPV contraindications
• past history of respiratory chronic disease (COPD, cystic fibrosis...)
• cardiac pulmonary edema
• Pre-defined intubation
• other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
• profound aplasia (white cells count <1000/mm 3)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the number of patients in each group who require endotracheal intubation with mechanical ventilation	28days	To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation-free to day 28	28 days

Trial Locations

Locations (1)

Ethics Committee of Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China