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Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients. (HDWOBPT)

Primary Purpose

Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Airvo 2; Ficher and Paykel HealthCare
Oxygen delivery via conventional nasal mask
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with

  • either hypoxemia (SpO2<90% with O2≥3L/min) ;
  • or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38).

Exclusion Criteria:

  • Patients below 18yo, pregnant or breastfeeding women;
  • Patients enrolled in another study excluding co-enrolment;
  • History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
  • Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
  • Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30;
  • Patient feeling nauseous or under recent fed condition (<1h).

Sites / Locations

  • IUCPQRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Conventional flow via nasal prongs

High flow nasal cannulas 20L/min

High flow nasal cannulas 40L/min

High flow nasal cannulas 60L/min

Arm Description

Oxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition.

Oxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition.

Oxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.

Oxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.

Outcomes

Primary Outcome Measures

Work of breathing
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)

Secondary Outcome Measures

Esophageal pressure-time product
Measured at the end of each period
Tidal volume
Measured at the end of each period
Comfort of breathing
Subjective evaluation at the end of each period
Blood gases
Arterial or capillary blood gases at the end of each period
Dyspnea
Evaluation on a borg scale at the end of each period
Respiratory rate
Measured at the end of each period
Heart rate
Measured at the end of each period
End-tidal carbon dioxide
Measured at the end of each period
Oxygen saturation
Measured at the end of each period

Full Information

First Posted
June 4, 2015
Last Updated
July 9, 2015
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02494154
Brief Title
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.
Acronym
HDWOBPT
Official Title
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.
Detailed Description
High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency. The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing. The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional flow via nasal prongs
Arm Type
Active Comparator
Arm Description
Oxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition.
Arm Title
High flow nasal cannulas 20L/min
Arm Type
Experimental
Arm Description
Oxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition.
Arm Title
High flow nasal cannulas 40L/min
Arm Type
Experimental
Arm Description
Oxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.
Arm Title
High flow nasal cannulas 60L/min
Arm Type
Experimental
Arm Description
Oxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.
Intervention Type
Device
Intervention Name(s)
Airvo 2; Ficher and Paykel HealthCare
Intervention Description
High flow nasal cannulas
Intervention Type
Device
Intervention Name(s)
Oxygen delivery via conventional nasal mask
Intervention Description
Low flow of oxygen delivered through conventional nasal prongs
Primary Outcome Measure Information:
Title
Work of breathing
Description
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Esophageal pressure-time product
Description
Measured at the end of each period
Time Frame
15 minutes
Title
Tidal volume
Description
Measured at the end of each period
Time Frame
15 minutes
Title
Comfort of breathing
Description
Subjective evaluation at the end of each period
Time Frame
15 minutes
Title
Blood gases
Description
Arterial or capillary blood gases at the end of each period
Time Frame
15 minutes
Title
Dyspnea
Description
Evaluation on a borg scale at the end of each period
Time Frame
15 minutes
Title
Respiratory rate
Description
Measured at the end of each period
Time Frame
15 minutes
Title
Heart rate
Description
Measured at the end of each period
Time Frame
15 minutes
Title
End-tidal carbon dioxide
Description
Measured at the end of each period
Time Frame
15 minutes
Title
Oxygen saturation
Description
Measured at the end of each period
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with either hypoxemia (SpO2<90% with O2≥3L/min) ; or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38). Exclusion Criteria: Patients below 18yo, pregnant or breastfeeding women; Patients enrolled in another study excluding co-enrolment; History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study; Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax); Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30; Patient feeling nauseous or under recent fed condition (<1h).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Delorme, PT, MSc
Phone
418-656-8711
Ext
3508
Email
mathieu.delorme.2@ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche, MD, PhD
Phone
418-656-8711
Ext
3298
Email
francois.lellouche@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Lellouche, MD, PhD
Organizational Affiliation
Fondation IUCPQ
Official's Role
Study Director
Facility Information:
Facility Name
IUCPQ
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Lellouche, MD, PhD
Phone
418-656-8711
Ext
3298
Email
francois.lellouche@criucpq.ulaval.ca

12. IPD Sharing Statement

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Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.

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