Respiration, ArtificialNCT00911378
Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation
A study testing Pressure support ventilation and Spontaneous breathing trials in people with Respiration, Artificial and Ventilator Weaning, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Respiration, Artificial, Ventilator Weaning
- What is being tested?
- Pressure support ventilation and Spontaneous breathing trials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2008to Sep 2009
- Phase
- Interventional
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mechanically ventilated patients for more than 24 hours
- Satisfies weaning criteria
- RSBI < 80
- Ratio of PaO2/FiO2 > 250
- Arterial partial pressure of oxygen more than 60 mm Hg and carbon dioxide less than 50 mm Hg
Who cannot join
- Systolic blood pressure of less than 100
- Arterial partial pressure of oxygen less than 60 mm Hg
- Poor sensorium
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
Ritesh Agarwal, MD, DM, +919914209825, riteshpgi@gmail.com
Ashutosh Aggarwal, MD, DM, +919914209824, ashutosh@indiachest.org
About this study
Official title: A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU
This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.
Read the detailed description
Patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, T tube trials are used for weaning. The outcomes are compared in the two groups.
- Conditions
- Respiration, Artificial, Ventilator Weaning
- Being tested
- Pressure support ventilation, Spontaneous breathing trials
- Keywords
- weaning, mechanical ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure support ventilationProcedure or surgery
Also called weaning by reduction of pressure support
These patients are weaned by gradual reduction of pressure support and extubated when they tolerate a pressure support of 7 cm of water for one hour.
Spontaneous breathing trialsProcedure or surgery
Also called Weaning by T-piece trials
These patients are weaned by giving a T piece trial with 8 cm of water pressure support and extubated when they tolerate it for one hour.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support ventilation | Active comparator | Patients in this arm are weaned by gradual reduction of pressure support Receives: Procedure: Pressure support ventilation |
| Spontaneous breathing trials | Active comparator | Patients in this arm are weaned by T piece trials Receives: Procedure: Spontaneous breathing trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weaning failure
Measured: 48 hours from extubation
Secondary outcomes (6)
Occurence of ventilator associated pneumonia
Measured: Until the date of discharge from hospital
Reintubation rates
Measured: 48 hours
Mortality rates
Measured: Until the time of discharge from hospital
Duration from start of weaning to extubation
Measured: In hospital stay
Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient
Measured: during ICU stay
The influence of weaning outcome on mortality and the other complications of mechanical ventilation
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Ashutosh Aggarwal, MD, DM, Study director, Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911378
- Sponsor's protocol ID
- weaning2009
- Status last verified
- Jun 2009
- First submitted
- 28 May 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
PubMed 7823995Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
PubMed 7921460Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
PubMed 9279224
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU
- ClinicalTrials.gov ID
- NCT00911378
- Acronym / sponsor ID
- weaning2009
- Conditions
- Respiration, Artificial, Ventilator Weaning
- Keywords
- weaning, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 1 Jun 2009 (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.
This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups.
Detailed description
Patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, T tube trials are used for weaning. The outcomes are compared in the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation | Active comparator | Procedure: Pressure support ventilationPatients in this arm are weaned by gradual reduction of pressure support |
| Spontaneous breathing trials | Active comparator | Procedure: Spontaneous breathing trialsPatients in this arm are weaned by T piece trials |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mechanically ventilated patients for more than 24 hours
- Satisfies weaning criteria
- RSBI < 80
- Ratio of PaO2/FiO2 > 250
- Arterial partial pressure of oxygen more than 60 mm Hg and carbon dioxide less than 50 mm Hg
Key exclusion criteria (3 listed)
- Systolic blood pressure of less than 100
- Arterial partial pressure of oxygen less than 60 mm Hg
- Poor sensorium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure support ventilationAlso: weaning by reduction of pressure supportThese patients are weaned by gradual reduction of pressure support and extubated when they tolerate a pressure support of 7 cm of water for one hour. | Procedure or surgery | Pressure support ventilation |
| Spontaneous breathing trialsAlso: Weaning by T-piece trialsThese patients are weaned by giving a T piece trial with 8 cm of water pressure support and extubated when they tolerate it for one hour. | Procedure or surgery | Spontaneous breathing trials |
Primary outcome
Rate of weaning failure
Time frame: 48 hours from extubation
6 secondary outcomes
Occurence of ventilator associated pneumonia
Time frame: Until the date of discharge from hospital
Reintubation rates
Time frame: 48 hours
Mortality rates
Time frame: Until the time of discharge from hospital
Duration from start of weaning to extubation
Time frame: In hospital stay
Role of various factors that may influence the weaning outcome and hence predict the probability of successful weaning in a patient
Time frame: during ICU stay
The influence of weaning outcome on mortality and the other complications of mechanical ventilation
Time frame: during hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
- Results publication: PubMed 7823995Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
- Results publication: PubMed 7921460Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
- Results publication: PubMed 9279224Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
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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.
Dr. Ashutosh Aggarwal, MD, DM study director
Department of Pulmonary Medicine and Critical Care, Postgraduate Institute of Medical Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure support ventilation and Spontaneous breathing trials in people with Respiration, Artificial and Ventilator Weaning, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Jun 2009. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ritesh Agarwal, MD, DM (+919914209825, riteshpgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weaning failure (time frame: 48 hours from extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911378, which also lists 3 linked publications.
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 22 Jun 2009.