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

This study has been completed.
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00632320
First received: March 2, 2008
Last updated: March 7, 2008
Last verified: March 2008
  Purpose

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.


Condition
Acute Respiratory Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: October 2004
Study Completion Date: August 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
S, 1, A
group (success or failure), case number, measurement method

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

respiratory therapy intensive Care unit in a medical center

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00632320

Locations
Taiwan
Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Mauo-Ying Bien, PhD School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC
  More Information

No publications provided

Responsible Party: Mauo-Ying Bien PhD, RPT, RRT/Assistant Professor, School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT00632320     History of Changes
Other Study ID Numbers: VGHIRB No.:93-09-02A, Grant 94CM-TMU-13, Grant NSC94-2314-B-038-039
Study First Received: March 2, 2008
Last Updated: March 7, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Ventilator, mechanical
Ventilator weaning
Rapid shallow breathing index
Continuous positive airway pressure
Receiver operating characteristic curve
COPD

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases

ClinicalTrials.gov processed this record on August 19, 2014