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

Shanghai Jiao Tong University logo

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)

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

Trial contacts and locations

1

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Central trial contact

dongjuan tang; bin he

Data sourced from clinicaltrials.gov

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