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The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

Primary Purpose

Chronic Respiratory Disease, COPD, Interstitial Lung Disease

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Deep breaths

About this trial

This is an interventional other trial for Chronic Respiratory Disease focused on measuring pulseoxymetry, capnography, Dead space, cardiac output, lung recruitment, deep breaths

Eligibility Criteria

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

Inclusion Criteria:

Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air
Ambulatory patients capable of performing 6 min walking test
Patients older than 18 years old.

Exclusion Criteria:

Patients with significant collagen disease causing Raynaud phenomenon.
Patients with hypothermia lower than 35 degrees Celsius
Patients with rest SpO2 values equal or lower than 80% on room air
Patients unable to perform PFTs
Patients unable to complete 6 min walking test without supp O2.
Patients unable to perform experimental deep breaths on CT scan

Sites / Locations

Facultad de Medicina y Hospital Universitario UANLRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with rest O2 desaturation

Arm Description

Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values

Outcomes

Primary Outcome Measures

Change in O2 saturation

A Saturation change greater than 4% will be considered significant

Secondary Outcome Measures

Vd/VT

In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol

Cardiac output (CO)

In a subset of 13 patients with the greater increase on O2Sat, CO will be measured during the same protocol

CT recruitment

In a subset of 13 patients with the greater increase on O2Sat, CT recruitment will be calculated using densitometry values during the same protocol

Full Information

NCT ID

NCT04139356

First Posted

October 23, 2019

Last Updated

October 23, 2019

Sponsor

Universidad Autonoma de Nuevo Leon

1. Study Identification

Unique Protocol Identification Number

NCT04139356

Brief Title

The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

Official Title

The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

November 15, 2019 (Anticipated)

Study Completion Date

December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Autonoma de Nuevo Leon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.

Detailed Description

There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.

6. Conditions and Keywords

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

Chronic Respiratory Disease, COPD, Interstitial Lung Disease

Keywords

pulseoxymetry, capnography, Dead space, cardiac output, lung recruitment, deep breaths

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with rest O2 desaturation

Arm Type

Experimental

Arm Description

Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values

Intervention Type

Procedure

Intervention Name(s)

Deep breaths

Intervention Description

Patients will undergo a 6 minutes protocol. Baseline: 1 minute normal breaths. Intervention: 1 minute with 10 deep breaths, 1 each 6 secs. Pulse-oxymetry will be continuously recorded.

Primary Outcome Measure Information:

Title

Change in O2 saturation

Description

A Saturation change greater than 4% will be considered significant

Time Frame

Lenght of experimental protocol: 6 minutes.

Secondary Outcome Measure Information:

Title

Vd/VT

Description

In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol

Time Frame

Lenght of experimental protocol: 6 minutes.

Title

Cardiac output (CO)

Description

In a subset of 13 patients with the greater increase on O2Sat, CO will be measured during the same protocol

Time Frame

Lenght of experimental protocol: 6 minutes.

Title

CT recruitment

Description

In a subset of 13 patients with the greater increase on O2Sat, CT recruitment will be calculated using densitometry values during the same protocol

Time Frame

Lenght of experimental protocol: 6 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air Ambulatory patients capable of performing 6 min walking test Patients older than 18 years old. Exclusion Criteria: Patients with significant collagen disease causing Raynaud phenomenon. Patients with hypothermia lower than 35 degrees Celsius Patients with rest SpO2 values equal or lower than 80% on room air Patients unable to perform PFTs Patients unable to complete 6 min walking test without supp O2. Patients unable to perform experimental deep breaths on CT scan

Central Contact Person:

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

Uriel Chavarria, MD

Phone

+528183482018

uriel_chavarria@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uriel Chavarria, MD

Organizational Affiliation

Facultad de Medicina y Hospital Universitario UANL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Facultad de Medicina y Hospital Universitario UANL

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64630

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uriel Chavarria, MD

Phone

+528183482018

uriel_chavarria@hotmail.com

12. IPD Sharing Statement

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The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

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