ARDSAPRVNCT03140579
Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS
An observational study of ARDS and Critical Illness, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Critical Illness, Ventilator-Induced Lung Injury
- What is being tested?
- APRV
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 31 Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients admitted to ICU ventilated with moderate or severe ARDS, based on the Berlin definition of ARDS.
Who may be able to join
- Age ≥ 18 years and < 80 years
- Weight > 35 Kg and BMI < 40
- Informed consent according to local regulations
- Hemoglobin ≥ 70 g/dl
- Haemodynamically stable > 4 hours
- Moderate to severe ARDS (PaO2/FIO2 < 26.6 kPa with positive end-expiratory pressure (PEEP) > 5 cmH2O) as per Berlin definition of ARDS
Who cannot join
- Expected survival < 72 hours
- Suspected pregnancy (negative pregnancy test required for women of child-bearing potential)
- Open abdomen
- Documented or suspected raised intracranial pressure
- Active air leak (pneumothorax, pneumomediastinum, subcutaneous emphysema)
- Morbid obesity BMI > 40
Show all 15Show fewer
- Recent < 1 week cardiac or thoracic surgery
- Unstable thorax and sternum with paradoxical chest wall movement
- Severe Chronic Respiratory Disease (COPD) - GOLD 3 or 4 emphysema with bullae
- Severe smoking (> 40 pack-year history)
- Liver Failure: Child-Pugh Class C
- Massive ascites
- Lung fibrosis
- Severe cardiac disease (one of the following): New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias
- Sickle cell disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Long Term PEEP Effect on Lung Homogeneity and Recruitment Using APRV Ventilation:Measurement of End Expiratory Lung Volume With Nitrogen Wash-out/wash-in Technique and End Expiratory Lung Impedance With EIT at Different Times.
This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS).
It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.
Read the detailed description
Ventilator-induced lung injury (VILI) is a well-recognised problem of ventilation in patients with ARDS, and is currently treated with lung-protective ventilation, which limits tidal volumes and airway pressures by applying higher levels of positive-end expiratory pressure (PEEP). However, it is not known whether higher levels of PEEP increases recruitment and homogeneity of ventilation within the lungs.
APRV is a mode of inverse ventilation, where high levels of PEEP are maintained with brief releases of pressure, and has been proposed as an appropriate method of ventilation in patients with ARDS.
This study will assess homogeneity of ventilation and recruitment in 15 patients before APRV is started, and 30, 60 and 120 mins after commencing APRV. It will do this using Electrical Impedance Tomography (EIT), nitrogen wash in/wash out technique, and lung strain.
- Conditions
- ARDS, Critical Illness, Ventilator-Induced Lung Injury
- Being tested
- APRV
- Keywords
- recruitment, lung homogeneity, airway pressure release ventilation
- Medical subject headings
- Critical Illness, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRVOther
Airway pressure release ventilation is a method of inverse ventilation, where high levels of positive end expiratory pressure are maintained to optimise oxygenation with brief releases of pressure to allow ventilation and release carbon dioxide. It is an approved and frequently used method of ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS
EIT will be measured at time APRVpre during a "low-flow maneuver" consisting of a brief switch to PC ventilation: with a flow of 4 L/min, airway pressure will be gradually increased up to 30 cmH20 in order to see how the lung changes elastically minimising resistance. EIT will also be measured after 30 min (time APRV30), 60 min (time APRV60), 120 min (time APRV120) since APRV has started.
Measured: 30, 60 and 120 mins
Secondary outcomes (2)
To assess recruitment at the beginning and after the end of APRV ventilation in patients with moderate-severe ARDS.
To assess recruitment measuring change in end expiratory lung impedance (EELI) with EIT technique, and EELV with nitrogen wash-out/wash-in technique.
Measured: 2 hours
To compare lung strain measured at APRVpre and after the end of APRV ventilation (APRVpost) in patients with moderate-severe ARDS
Strain will be calculated at time APRVpre using the strain formula (TV/EELV)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Why it stopped: Study not undertaken due to COVID and capacity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Camporota, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140579
- Sponsor's protocol ID
- 123456789
- Acronym
- APRV
- Status last verified
- Aug 2022
- First submitted
- 2 May 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All shared data will be as a mean and not as individual
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Long Term PEEP Effect on Lung Homogeneity and Recruitment Using APRV Ventilation:Measurement of End Expiratory Lung Volume With Nitrogen Wash-out/wash-in Technique and End Expiratory Lung Impedance With EIT at Different Times.
- ClinicalTrials.gov ID
- NCT03140579
- Acronym / sponsor ID
- APRV / 123456789
- Conditions
- ARDS, Critical Illness, Ventilator-Induced Lung Injury
- Keywords
- recruitment, lung homogeneity, airway pressure release ventilation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not undertaken due to COVID and capacity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 4 May 2017 (actual)
- 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 evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS).
It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.
Detailed description
Ventilator-induced lung injury (VILI) is a well-recognised problem of ventilation in patients with ARDS, and is currently treated with lung-protective ventilation, which limits tidal volumes and airway pressures by applying higher levels of positive-end expiratory pressure (PEEP). However, it is not known whether higher levels of PEEP increases recruitment and homogeneity of ventilation within the lungs.
APRV is a mode of inverse ventilation, where high levels of PEEP are maintained with brief releases of pressure, and has been proposed as an appropriate method of ventilation in patients with ARDS.
This study will assess homogeneity of ventilation and recruitment in 15 patients before APRV is started, and 30, 60 and 120 mins after commencing APRV. It will do this using Electrical Impedance Tomography (EIT), nitrogen wash in/wash out technique, and lung strain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients admitted to ICU ventilated with moderate or severe ARDS, based on the Berlin definition of ARDS.
Key inclusion criteria (6 listed)
- Age ≥ 18 years and < 80 years
Key exclusion criteria (15 listed)
- Expected survival < 72 hours
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 |
|---|---|---|
| APRVAirway pressure release ventilation is a method of inverse ventilation, where high levels of positive end expiratory pressure are maintained to optimise oxygenation with brief releases of pressure to allow ventilation and release carbon dioxide. It is an approved and frequently used method of ventilation. | Other | – |
Primary outcome
To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS
Time frame: 30, 60 and 120 mins
EIT will be measured at time APRVpre during a "low-flow maneuver" consisting of a brief switch to PC ventilation: with a flow of 4 L/min, airway pressure will be gradually increased up to 30 cmH20 in order to see how the lung changes elastically minimising resistance. EIT will also be measured after 30 min (time APRV30), 60 min (time APRV60), 120 min (time APRV120) since APRV has started.
2 secondary outcomes
To assess recruitment at the beginning and after the end of APRV ventilation in patients with moderate-severe ARDS.
Time frame: 2 hours
To compare lung strain measured at APRVpre and after the end of APRV ventilation (APRVpost) in patients with moderate-severe ARDS
Time frame: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No. All shared data will be as a mean and not as individual
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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.
Luigi Camporota principal investigator
Guy's and St Thomas' NHS Foundation Trust
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 ARDS and Critical Illness, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Aug 2022. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS (time frame: 30, 60 and 120 mins). 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 17 Aug 2022.