Covid19NCT04873336
Closed Loop Ventilation in Patients With COVID-19
An observational study of Covid19 and ARDS, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intellivent ASV
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 16 Oct 2021
- How long will I take part?
- 28 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with COVID-19 who received invasive mechanical ventilation due to respiratory failure in intensive care unit
Who may be able to join
- COVID-19 is confirmed with RT-PCR
- ->18 years of age
- Being intubated less than 24 hours
- Not being planned to be extubated in 24 hours
Who cannot join
- COVID-19 is not confirmed with RT-PCR
- Having an impaired hemodynamic status
- Esophageal pathologies
- Bronchopleural fistula
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Izmir, 35110
About this study
Official title: Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19
Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.
Read the detailed description
Patients will be enrolled in the first 24 hours of admission to the intensive care unit. APACHE-2 and SAPS-2 scores will be noted 24 hours after admission. COVID-19 pneumonia will be confirmed according to World Health Organization (WHO) interim guidance. Level of sedation will be monitored with Ramsey Sedation Scale.
An esophageal balloon will be inserted in order to measure transpulmonary pressure(Ptp). The proper localization will be estimated according to ear-nose-xiphoid length. Localization of the balloon will be confirmed with the Baydur maneuver. Mojoli methods will be used to optimize the balloon filling volume.
All patients will be mechanically ventilated under Intellivent-ASV mode. Initial settings will based on predicted body weight. 45 cmH2O will be determined as target end-tidal carbondiokside (ETCO2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. Safe pH value will be determined 7.25 independent from ETCO2 levels in patients who will be applied lung protective ventilation. FiO2 and PEEP will be set to maintain an SpO2 of 88-92%.
Ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. Targeted inspiratory transpulmonary pressure (Ptpinsp) was determined to be below 20 cmH2O. If Ptpinsp exceeds 20 cmH2O, minute-volume (MinVol) will be decreased by 10%. Minvol will be reduced below 100% if necessary, to achieve the target. Expiratory transpulmonary pressure (Ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. Targeted Ptpexp was determined from 0 to 3 cmH2O. If Ptpexp is below 0 cmH2O, PEEP will be increased until Ptpexp is positive. If Ptpexp exceed 3 mH2O, PEEP will be decreased until Ptpexp is below 3 mH2O. Transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. All measurement will be made in passive condition. Transpulmonary pressure measurement will continue until the patient is awake.
- Being tested
- Intellivent ASV
- Keywords
- Mechanical ventilation, Adaptive support ventilation, Transpulnonary pressure, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellivent ASVDevice
A closed loop mechanical ventilation mode that adjusts oxygenization and ventilation automatically
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Transpulmonary Pressure (Ptpins)
Ptpinsp will be measured with an inspiratory hold maneuver
Measured: The first 24 hours of mechanical ventilation
Secondary outcomes (1)
Expiratory Transpulmonary Pressure (Ptexp)
Ptpexp will be measured with an expiratory hold maneuver
Measured: The first 24 hours of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Apr 2021
- Primary completion15 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Investigators
- Suleyman Yildirim, M.D., Principal investigator, University of Health Sciences, Dr. Suat Seren Chest Diseases and Surgery Training and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873336
- Sponsor's protocol ID
- IGHCEAH-ICU-5
- Status last verified
- Nov 2021
- First submitted
- 4 May 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04873336
- Acronym / sponsor ID
- IGHCEAH-ICU-5
- Keywords
- Mechanical ventilation, Adaptive support ventilation, Transpulnonary pressure, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 5 May 2021 (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.
Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.
Detailed description
Patients will be enrolled in the first 24 hours of admission to the intensive care unit. APACHE-2 and SAPS-2 scores will be noted 24 hours after admission. COVID-19 pneumonia will be confirmed according to World Health Organization (WHO) interim guidance. Level of sedation will be monitored with Ramsey Sedation Scale.
An esophageal balloon will be inserted in order to measure transpulmonary pressure(Ptp). The proper localization will be estimated according to ear-nose-xiphoid length. Localization of the balloon will be confirmed with the Baydur maneuver. Mojoli methods will be used to optimize the balloon filling volume.
All patients will be mechanically ventilated under Intellivent-ASV mode. Initial settings will based on predicted body weight. 45 cmH2O will be determined as target end-tidal carbondiokside (ETCO2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. Safe pH value will be determined 7.25 independent from ETCO2 levels in patients who will be applied lung protective ventilation. FiO2 and PEEP will be set to maintain an SpO2 of 88-92%.
Ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. Targeted inspiratory transpulmonary pressure (Ptpinsp) was determined to be below 20 cmH2O. If Ptpinsp exceeds 20 cmH2O, minute-volume (MinVol) will be decreased by 10%. Minvol will be reduced below 100% if necessary, to achieve the target. Expiratory transpulmonary pressure (Ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. Targeted Ptpexp was determined from 0 to 3 cmH2O. If Ptpexp is below 0 cmH2O, PEEP will be increased until Ptpexp is positive. If Ptpexp exceed 3 mH2O, PEEP will be decreased until Ptpexp is below 3 mH2O. Transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. All measurement will be made in passive condition. Transpulmonary pressure measurement will continue until the patient is awake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COVID-19 who received invasive mechanical ventilation due to respiratory failure in intensive care unit
Key inclusion criteria (4 listed)
- COVID-19 is confirmed with RT-PCR
- ->18 years of age
- Being intubated less than 24 hours
- Not being planned to be extubated in 24 hours
Key exclusion criteria (4 listed)
- COVID-19 is not confirmed with RT-PCR
- Having an impaired hemodynamic status
- Esophageal pathologies
- Bronchopleural fistula
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 |
|---|---|---|
| Intellivent ASVA closed loop mechanical ventilation mode that adjusts oxygenization and ventilation automatically | Device | – |
Primary outcome
Inspiratory Transpulmonary Pressure (Ptpins)
Time frame: The first 24 hours of mechanical ventilation
Ptpinsp will be measured with an inspiratory hold maneuver
1 secondary outcome
Expiratory Transpulmonary Pressure (Ptexp)
Time frame: The first 24 hours of mechanical ventilation
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 16 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Suleyman Yildirim, M.D. principal investigator
University of Health Sciences, Dr. Suat Seren Chest Diseases and Surgery Training and Research Center
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 Covid19 and ARDS, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 16 Nov 2021. 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 Turkey (Türkiye). 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?
Inspiratory Transpulmonary Pressure (Ptpins) (time frame: The first 24 hours of mechanical ventilation). 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 16 Nov 2021.