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

Respiratory Failure Clinical Trial

— HDWOBPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02494154
• Other study ID #: IUCPQ-HDWOBPT
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: July 9, 2015
• Start date: May 2015

Study information

• Verified date: July 2015
• Source: Laval University
• Contact: Mathieu Delorme, PT, MSc
• Phone: 418-656-8711
• Email: mathieu.delorme.2[@]ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Airvo 2; Ficher and Paykel HealthCare
High flow nasal cannulas
• Oxygen delivery via conventional nasal mask
Low flow of oxygen delivered through conventional nasal prongs

Locations

Country	Name	City	State
Canada	IUCPQ	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Esophageal pressure-time product	Measured at the end of each period	15 minutes	No
Secondary	Tidal volume	Measured at the end of each period	15 minutes	No
Secondary	Comfort of breathing	Subjective evaluation at the end of each period	15 minutes	No
Secondary	Blood gases	Arterial or capillary blood gases at the end of each period	15 minutes	No
Secondary	Dyspnea	Evaluation on a borg scale at the end of each period	15 minutes	No
Secondary	Respiratory rate	Measured at the end of each period	15 minutes	No
Secondary	Heart rate	Measured at the end of each period	15 minutes	No
Secondary	End-tidal carbon dioxide	Measured at the end of each period	15 minutes	No
Secondary	Oxygen saturation	Measured at the end of each period	15 minutes	No