Respiration, ArtificialNCT01165528
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
A study testing type of mechanical ventilation in people with Respiration, Artificial and Respiratory Distress Syndrome, Adult, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Respiration, Artificial, Respiratory Distress Syndrome, Adult
- What is being tested?
- type of mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Jun 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Who cannot join
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Respiratory intensive care unit, PGIMER
Chandigarh, Chandigarh, 160012
Ritesh Agarwal, MD, DM, MAMS, FCCP, 9914209825 ext. 2756825, riteshpgi@gmail.com
Arjun Srinivasan, M.D.
About this study
Official title: Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
Read the detailed description
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
- Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
- Being tested
- type of mechanical ventilation
- Medical subject headings
- Respiratory Aspiration, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of mechanical ventilationProcedure or surgery
patients are randomized to receive one of the two types of mechanical ventilation for ARDS
| Study group | Role | What they receive |
|---|---|---|
| Adaptive support ventilation in ARDS | Active comparator | patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol Receives: Procedure: type of mechanical ventilation |
| conventional ventilation strategy in ARDS | Active comparator | Not described Receives: Procedure: type of mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Measured: up to 4 weeks
duration of ICU stay
Measured: up to 4 weeks
duration of hospital stay
Measured: up to 8 weeks
Secondary outcomes (3)
Mortality
Measured: up to 8 weeks
ease of use of ventilator mode
Measured: up to 4 weeks
frequency of blood gas analysis
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Arjun srinivasan, M.D., Principal investigator, dept of pulmonary medicine & critical care, PGIMER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165528
- Sponsor's protocol ID
- ASVtrial
- Status last verified
- Dec 2009
- First submitted
- 16 Jul 2010
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Agarwal R, Srinivasan A, Aggarwal AN, Gupta D. Adaptive support ventilation for complete ventilatory support in acute respiratory distress syndrome: a pilot, randomized controlled trial. Respirology. 2013 Oct;18(7):1108-15. doi: 10.1111/resp.12126.
PubMed 23711230
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01165528
- Acronym / sponsor ID
- ASVtrial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (estimated)
- First posted
- 20 Jul 2010 (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.
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
Detailed description
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
- Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive support ventilation in ARDS | Active comparator | Procedure: type of mechanical ventilationpatients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol |
| conventional ventilation strategy in ARDS | Active comparator | Procedure: type of mechanical ventilation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Key exclusion criteria (3 listed)
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
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 |
|---|---|---|
| type of mechanical ventilationpatients are randomized to receive one of the two types of mechanical ventilation for ARDS | Procedure or surgery | Adaptive support ventilation in ARDS, conventional ventilation strategy in ARDS |
Primary outcome
Duration of mechanical ventilation
Time frame: up to 4 weeks
duration of ICU stay
Time frame: up to 4 weeks
duration of hospital stay
Time frame: up to 8 weeks
3 secondary outcomes
Mortality
Time frame: up to 8 weeks
ease of use of ventilator mode
Time frame: up to 4 weeks
frequency of blood gas analysis
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Derived from this study: PubMed 23711230Agarwal R, Srinivasan A, Aggarwal AN, Gupta D. Adaptive support ventilation for complete ventilatory support in acute respiratory distress syndrome: a pilot, randomized controlled trial. Respirology. 2013 Oct;18(7):1108-15. doi: 10.1111/resp.12126.
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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.
Arjun srinivasan, M.D. principal investigator
dept of pulmonary medicine & critical care, PGIMER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type of mechanical ventilation in people with Respiration, Artificial and Respiratory Distress Syndrome, Adult, 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 4 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 20 Jul 2010. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. 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 NCT01165528, which also lists 1 linked publication.
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 20 Jul 2010.