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
• Interventions: Device: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation; Other: standard low flow therapy; Device: high flow nasal oxygen therapy

• 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

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation	association of high flow nasal oxygen therapy and non invasive positive pressure ventilation	In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.
standard low flow therapy	standard low flow therapy	In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.
high flow nasal oxygen therapy	high flow nasal oxygen therapy	In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.

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