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

Primary Purpose

Acute Respiratory Failure With Hypercapnia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

standard low flow therapy

high flow nasal oxygen therapy

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

About this trial

This is an interventional treatment trial for Acute Respiratory Failure With Hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Ethics Committee of Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

standard low flow therapy

high flow nasal oxygen therapy

Noninvasive ventilation

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mechanical ventilation-free to day 28

Full Information

NCT ID

NCT03229460

First Posted

July 23, 2017

Last Updated

December 3, 2018

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03229460

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure With Hypercapnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard low flow therapy

Arm Type

Active Comparator

Arm Description

Arm Title

high flow nasal oxygen therapy

Arm Type

Experimental

Arm Description

Arm Title

Noninvasive ventilation

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

standard low flow therapy

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

high flow nasal oxygen therapy

Intervention Description

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%.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

28days

Secondary Outcome Measure Information:

Title

mechanical ventilation-free to day 28

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

bin he

Phone

021-25077828

hebinicu@139.com

First Name & Middle Initial & Last Name or Official Title & Degree

dongjuan tang

317582862@qq.com

Facility Information:

Facility Name

Ethics Committee of Xinhua Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guangyu Chen, PhD

Phone

+86-02125076143

xinhuacru@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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