High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- the number of patients in each group who require endotracheal intubation with mechanical ventilation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: standard low flow therapy (Other)
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.
Intervention: high flow nasal oxygen therapy (Device)
Noninvasive 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.
Intervention: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation (Device)
Outcomes
Primary Outcomes
the number of patients in each group who require endotracheal intubation with mechanical ventilation
Time Frame: 28days
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Secondary Outcomes
- mechanical ventilation-free to day 28(28 days)
Investigators
Bin He
M.D./Ph.D.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine