Ventilator LungNCT05690867
Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery
A study of Ventilator Lung, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Lung
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 5 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA1-2 , >18 years old patients having upper abdominal surgery
Who cannot join
- chronic obstructive lung disease, interstitial lung disease
- chronic renal failure
- Child-Pugh > 6 liver disease
- Patients who don't give consent
- NYHA > 2 heart failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, 34093
About this study
Official title: Comparison of Pressure and Volume Controlled Ventilation in Terms of Mechanical Power in Upper Abdominal Surgery
Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation
Read the detailed description
The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)
- Conditions
- Ventilator Lung
- Being tested
- Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes, Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes
- Keywords
- mechanical power, volume controlled ventilation, pressure controlled ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting with volume controlled ventilation and changing the ventilation mode every 20 minutesOther
group 1 starts with volume controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to pressure controlled ventilation after letting washout we take three consecutive measurements at pressure controlled ventilation and we will repeat this protocol during surgery
Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutesOther
group 2 starts with pressure controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to volume controlled ventilation after letting washout we take three consecutive measurements at volume controlled ventilation and we will repeat this protocol during surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | group 1 starts with volume controlled ventilation Receives: Other: Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes |
| Group 2 | Other | group 2 starts with pressure controlled ventilation Receives: Other: Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculation of mechanical power changes in two different ventilation modes
mechanical power will be calculated using the Van der Meijden's formula for pressure support ventilation and Gattinoni's formula for volume controlled ventilation and two mechanical powers will be compared
Measured: change from at the beginning of surgery till the end of surgery
Secondary outcomes (2)
postoperative pulmonary complications
postoperative pulmonary complication including pneumonia, acute lung injury, respiratory failure requiring reintubation
Measured: post-operative 7 days
hospitalisation time
up to 20 days
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start5 Sep 2022
- Primary completion5 Nov 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator LungStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Nil Kırsan, Istanbul University
- Investigators
- Istanbul University, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690867
- Sponsor's protocol ID
- 2021-2081
- Status last verified
- Jan 2023
- First submitted
- 18 Oct 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
PubMed 28701178van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
PubMed 31359082
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pressure and Volume Controlled Ventilation in Terms of Mechanical Power in Upper Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05690867
- Acronym / sponsor ID
- 2021-2081
- Conditions
- Ventilator Lung
- Keywords
- mechanical power, volume controlled ventilation, pressure controlled ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 19 Jan 2023 (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.
Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation
Detailed description
The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Starting with volume controlled ventilation and changing the ventilation mode every 20 minutesgroup 1 starts with volume controlled ventilation |
| Group 2 | Other | Other: Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutesgroup 2 starts with pressure controlled ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1-2 , >18 years old patients having upper abdominal surgery
Key exclusion criteria (5 listed)
- chronic obstructive lung disease, interstitial lung disease
- chronic renal failure
- Child-Pugh > 6 liver disease
- Patients who don't give consent
- NYHA > 2 heart failure
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 |
|---|---|---|
| Starting with volume controlled ventilation and changing the ventilation mode every 20 minutesgroup 1 starts with volume controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to pressure controlled ventilation after letting washout we take three consecutive measurements at pressure controlled ventilation and we will repeat this protocol during surgery | Other | Group 1 |
| Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutesgroup 2 starts with pressure controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to volume controlled ventilation after letting washout we take three consecutive measurements at volume controlled ventilation and we will repeat this protocol during surgery | Other | Group 2 |
Primary outcome
calculation of mechanical power changes in two different ventilation modes
Time frame: change from at the beginning of surgery till the end of surgery
mechanical power will be calculated using the Van der Meijden's formula for pressure support ventilation and Gattinoni's formula for volume controlled ventilation and two mechanical powers will be compared
2 secondary outcomes
postoperative pulmonary complications
Time frame: post-operative 7 days
hospitalisation time
Time frame: up to 20 days
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 19 Jan 2023.
- Background: PubMed 28701178Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
- Background: PubMed 31359082van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
- 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.
Istanbul University principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ventilator Lung, run by Istanbul University 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 1 inclusion and 5 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 19 Jan 2023. 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?
calculation of mechanical power changes in two different ventilation modes (time frame: change from at the beginning of surgery till the end of surgery). 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 NCT05690867, which also lists 2 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 19 Jan 2023.