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NCT01191528 Clinical Trial

The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)

Postoperative Care Clinical Trial

Official title:
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index in Adult Post-operative Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01191528
Other study ID # AH2ESCAP
Secondary ID
Status Completed
Phase N/A
First received August 30, 2010
Last updated December 10, 2010
Start date August 2010
Est. completion date December 2010

Study information
Verified date December 2010
Source Allenmore Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.

Description:

A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night.

Subjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Age greater than 18

- Increased Body Mass Index (BMI) > 31

- History of chronic obstructive pulmonary disease (COPD)

- History of Sleep Apnea

Exclusion criteria:

- Respiratory failure

- Isolation requirements

- Surgical patients admitted to 2 West or ICU

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Device:
• capnostream 20, Oridian Medical 1987 ltd, Needham MA
Oxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor. End-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals.

Locations
Country Name City State
United States Allenmore Hospital Tacoma Washington

Sponsors (1)
Lead Sponsor Collaborator
Allenmore Hospital

Country where clinical trial is conducted

United States, 

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