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

NCT03229460 | Unknown DMC FDA Device

• 1 other identifier: XH-17-008
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure With Hypercapnia

Outcome Measures

Primary Outcomes (1)

• the number of patients in each group who require endotracheal intubation with mechanical ventilation

  To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

  28days

Secondary Outcomes (1)

• mechanical ventilation-free to day 28

  28 days

Study Arms (3)

standard low flow therapy

ACTIVE COMPARATOR

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.

Other: standard low flow therapy

high flow nasal oxygen therapy

EXPERIMENTAL

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.

Device: high flow nasal oxygen therapy

Noninvasive ventilation

PLACEBO COMPARATOR

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.

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

Interventions

standard low flow therapy OTHER

In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.

standard low flow therapy

high flow nasal oxygen therapy DEVICE

The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

high flow nasal oxygen therapy

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

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

Noninvasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Central Study Contacts

bin he

CONTACT

021-25077828; hebinicu@139.com

dongjuan tang

CONTACT

317582862@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D./Ph.D.

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 25, 2017
• Study Start: August 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-11

Locations

CN (1)