Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
This study has been completed.
Sponsor:
Taipei Veterans General Hospital,Taiwan
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
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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
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 Signs and Symptoms, Respiratory Signs and Symptoms Lung Diseases |
ClinicalTrials.gov processed this record on May 19, 2013