The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

NCT ID: NCT04139356

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2019-12-15

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.

Conditions

Chronic Respiratory Disease; COPD; Interstitial Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with rest O2 desaturation

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

Group Type: EXPERIMENTAL

Deep breaths

Intervention Type: PROCEDURE

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.

Interventions

Deep breaths

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Uriel Chavarria-Martinez

Professor of Internal Medicine Pulmonary and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uriel Chavarria, MD

Role: PRINCIPAL_INVESTIGATOR

Facultad de Medicina y Hospital Universitario UANL

Locations

Facultad de Medicina y Hospital Universitario UANL

Monterrey, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Uriel Chavarria, MD

Role: CONTACT

uriel_chavarria@hotmail.com

+528183482018

Facility Contacts

Uriel Chavarria, MD

Role: primary

uriel_chavarria@hotmail.com

+528183482018

Other Identifiers

UAutonomaNL

Identifier Type: -

Identifier Source: org_study_id