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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Acute Respiratory Failure With Hypercapnia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03229460

XH-17-008

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups, including a placebo group

standard low flow therapy

Active Comparator group

Description:

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.

Treatment:

Other: standard low flow therapy

high flow nasal oxygen therapy

Experimental group

Description:

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.

Treatment:

Device: high flow nasal oxygen therapy

Noninvasive ventilation

Placebo Comparator group

Description:

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.

Treatment:

Device: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation