High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: Hospital Italiano de Buenos Aires (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02860273
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: High Flow Nasal Cannula Oxygen; Device: Treadmill	N/A

Detailed Description

Design: interventional, crossover, randomized.

The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using High Flow Nasal Cannula Oxygen (HFNCO).

Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using High Flow Nasal Cannula Oxygen and the other breathing room air.

In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.

The following variables will be measured before, during and after each test:

Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Flow Nasal Cannula Oxygen Incremental Load Treadmill Test (ILTT) using HFNCO at 21% Constant Treadmill Load Test (CTLT) using HFNCO at 21%	Device: High Flow Nasal Cannula Oxygen; Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.; Other Names: HFNCO
Other: Control Group Incremental Load Treadmill Test (ILTT) at Room Air Constant Treadmill Load Test (CTLT) at Room Air	Device: Treadmill; Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.

Outcome Measures

Primary Outcome Measures

1. Difference in Exercise capacity - Maximun Walking Time Tolerated [Baseline and 48 hs after baseline]

   Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air

Secondary Outcome Measures

1. Difference in Dyspnea [Baseline and 48 hs after baseline]

   Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air

2. Difference in Cardiac Rate [Baseline and 48 hs after baseline]

   Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air

3. Difference in Oxygen Saturation [Baseline and 48 hs after baseline]

   Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air

4. Difference in Global Comfort [Baseline and 48 hs after baseline]

   Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air

5. Difference in Lower Limbs Fatigue [Baseline and 48 hs after baseline]

   Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air

6. Difference in Respiratory Rate [Baseline and 48 hs after baseline]

   Difference in Respiratory rate in breaths per minute between HFNCO and Room air

7. Difference in Blood Pressure [Baseline and 48 hs after baseline]

   Difference in of Blood pressure in mmHg between HFNCO and Room air

8. Difference in Exercise capacity - Maximun Walking Speed Reached [Baseline and 48 hs after baseline]

   Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinically stable defined as four weeks without exacerbation.

• Signed Informed consent

Exclusion Criteria:

• Long term oxygen therapy (LTOT) or oxygen needs during exercise

• Any neuromuscular or cardiovascular condition that limits test performance

• Refusal to participate

• Contraindication for exercise

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Italiano de Buenos Aires	Buenos Aires		Argentina	C1181ACH

Sponsors and Collaborators

• Hospital Italiano de Buenos Aires

Investigators

• Principal Investigator: Nicolás NR Roux, PT-RT, Hospital Italiano de Buenos Aires

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Global initiative for Chronic Obstructive Lung Disease. Update 2016

Publications

None provided.

• Responsible Party: Hospital Italiano de Buenos Aires
• ClinicalTrials.gov Identifier: NCT02860273
• Other Study ID Numbers: 2728
• First Posted: Aug 9, 2016
• Last Update Posted: Mar 12, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Hospital Italiano de Buenos Aires: Pulmonary Rehabilitation; COPD; High Flow Nasal Cannula; HFNC; Aerobic capacity

Study Results

No Results Posted as of Mar 12, 2018