Acute Respiratory FailureNCT00632320
Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
An observational study of Acute Respiratory Failure, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 98 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2004to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: respiratory therapy intensive Care unit in a medical center
Who may be able to join
- 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
Who cannot join
- having ongoing lung or neuromuscular disease and signs of increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Keywords
- Ventilator, mechanical, Ventilator weaning, Rapid shallow breathing index, Continuous positive airway pressure, Receiver operating characteristic curve, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S, 1, A | group (success or failure), case number, measurement method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies.
Measured: Before the patient processing weaning trials
Secondary outcomes (1)
Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions.
Measured: Before the patient processing weaning trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startOct 2004
- Primary completionDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Investigators
- Mauo-Ying Bien, PhD, Principal investigator, School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632320
- Sponsor's protocol ID
- VGHIRB No.:93-09-02A
- Other IDs
- Grant 94CM-TMU-13, Grant NSC94-2314-B-038-039
- Status last verified
- Mar 2008
- First submitted
- 2 Mar 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
- ClinicalTrials.gov ID
- NCT00632320
- Acronym / sponsor ID
- VGHIRB No.:93-09-02A
- Conditions
- Acute Respiratory Failure
- Keywords
- Ventilator, mechanical, Ventilator weaning, Rapid shallow breathing index, Continuous positive airway pressure, Receiver operating characteristic curve, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S, 1, A | – | –group (success or failure), case number, measurement method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- respiratory therapy intensive Care unit in a medical center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- having ongoing lung or neuromuscular disease and signs of increased intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauo-Ying Bien, PhD principal investigator
School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2008.