NCT02494154

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

June 4, 2015

Last Update Submit

July 9, 2015

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 minutes

Secondary Outcomes (9)

  • Esophageal pressure-time product

    15 minutes

  • Tidal volume

    15 minutes

  • Comfort of breathing

    15 minutes

  • Blood gases

    15 minutes

  • Dyspnea

    15 minutes

  • +4 more secondary outcomes

Study Arms (4)

Conventional flow via nasal prongs

ACTIVE COMPARATOR

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

Device: Oxygen delivery via conventional nasal mask

High flow nasal cannulas 20L/min

EXPERIMENTAL

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.

Device: Airvo 2; Ficher and Paykel HealthCare

High flow nasal cannulas 40L/min

EXPERIMENTAL

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

Device: Airvo 2; Ficher and Paykel HealthCare

High flow nasal cannulas 60L/min

EXPERIMENTAL

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

Device: Airvo 2; Ficher and Paykel HealthCare

Interventions

Airvo 2; Ficher and Paykel HealthCareDEVICE

High flow nasal cannulas

High flow nasal cannulas 20L/minHigh flow nasal cannulas 40L/minHigh flow nasal cannulas 60L/min
Oxygen delivery via conventional nasal maskDEVICE

Low flow of oxygen delivered through conventional nasal prongs

Conventional flow via nasal prongs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ

Québec, Quebec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • François Lellouche, MD, PhD

    Fondation IUCPQ

    STUDY DIRECTOR

Central Study Contacts

Mathieu Delorme, PT, MSc

CONTACT

418-656-8711mathieu.delorme.2@ulaval.ca

François Lellouche, MD, PhD

CONTACT

418-656-8711francois.lellouche@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

July 10, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

CA(1)