The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

NCT04139356 | Unknown DMC

• 1 other identifier: UAutonomaNL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Disease; COPD; Interstitial Lung Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in O2 saturation

  A Saturation change greater than 4% will be considered significant

  Lenght of experimental protocol: 6 minutes.

Secondary Outcomes (3)

• Vd/VT

  Lenght of experimental protocol: 6 minutes.

• Cardiac output (CO)

  Lenght of experimental protocol: 6 minutes.

• CT recruitment

  Lenght of experimental protocol: 6 minutes.

Study Arms (1)

Patients with rest O2 desaturation

EXPERIMENTAL

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

Procedure: Deep breaths

Interventions

Deep breaths 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.

Patients with rest O2 desaturation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Facultad de Medicina y Hospital Universitario UANL

Monterrey, Nuevo León, 64630, Mexico

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Uriel Chavarria, MD

  Facultad de Medicina y Hospital Universitario UANL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uriel Chavarria, MD

CONTACT

+528183482018; uriel_chavarria@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine Pulmonary and Critical Care

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

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: September 1, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 15, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

ME (1)