Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

March 7, 2008 updated by: Taipei Veterans General Hospital, Taiwan

Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.

Study Overview

Status

Completed

Conditions

Acute Respiratory Failure

Detailed Description

98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taipei, Taiwan, 112
    - Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

respiratory therapy intensive Care unit in a medical center

Description

Inclusion Criteria:

intubated medical patients with mechanically ventilated more than 48 hours
clinically ready for weaning
Glasgow coma scales were at least 8
their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable

Exclusion Criteria:

having ongoing lung or neuromuscular disease and signs of increased intracranial pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
S, 1, A group (success or failure), case number, measurement method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies. Time Frame: Before the patient processing weaning trials	Before the patient processing weaning trials

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions. Time Frame: Before the patient processing weaning trials	Before the patient processing weaning trials

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

Principal Investigator: Mauo-Ying Bien, PhD, School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

March 2, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)