Mechanical VentilationNCT06625099
Investigation of the Optimum PEEP Mechanical Power Relationship
An observational study of Mechanical Ventilation and Mechanical Power, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of standard and optimum positive end expiratory pressures on mechanical power during laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation, Mechanical Power, Optimum PEEP
- What is being tested?
- Mechanical Ventilation (MV) with Low PEEP and Mechanical Ventilation (MV) with Optimum PEEP
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2024to 5 Oct 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo laparoscopic cholecystectomy in the operating rooms of Kocaeli City Hospital will constitute the study universe.
Who may be able to join
- within the appropriate age range
- agreeing to participate in the study
- again receiving lancetesthesia
- volume controlled ventilation
- no known lung disease
- no known coronary artery disease
- ASA class 1-2 patients
Who cannot join
- . Patients who do not want to be included in the study will not be included
- Patients with intraoperative deep hypotension (mean arterial pressure \<50) will be excluded.
- Those who develop intraoperative hypothermia or have other anesthesia complications will be excluded.
- Patients who will not be extubated postoperatively will be excluded from the study.
- Those with neurological diseases or those using psychiatric medications will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Different Positive Expiratory Pressure Levels on Patient Oxygenation and Mechanical Power Values in Laparoscopic Surgeries
The aim of this study is to compare the effects of standard and optimum positive end expiratory pressures on mechanical power during laparoscopic surgeries.
Read the detailed description
Perioperative pulmonary complications and ventilator-associated lung injury are challenging issues for anesthesiologists, especially after laparoscopic surgeries. An increasing number of studies suggest lung protective ventilation (LPV) strategies in these patients. It is recommended that patients\&; driving pressure be kept low during LPV and positive expiratory pressure (PEEP) be applied to keep the lungs open. However, high PEEP values cannot be adequately applied in laparoscopic surgeries to reduce the restrictive peak pressure for LPV. In laparoscopic surgeries, the patients position and increased intra-abdominal pressure create pressure on the lungs. However, when the applied positive pressure ventilation is insufficient in patients, it can cause atelectasis, and when it is excessive, it can cause barotrauma or volutrauma. The threshold values determined for all these possible complications during LPV should be evaluated together.
Gattinoni and colleagues (2016) explained the effect of mechanical ventilation on the lungs through a work/time formula and formulated the energy used during this work. The applied energy is spent on opening the lungs and ventilation, while the excess is consumed due to heat and resistance in the respiratory tract. The unit of this energy can be formulated in a simplified way as joule/second. The mechanical power formula makes it easier to follow by providing a single parameter instead of different threshold values for barotrauma, volutrauma and atelectrauma for the lungs. Studies have shown that applying energy over 12.6 joules is associated with lung damage. On the other hand, the relationship between the optimum mechanical power (MP) value during ventilation and low and high PEEP is not yet fully known.
In laparoscopic surgeries, high PEEP application may help keep the lungs open and increase ventilation, but it may cause higher mechanical power application. In this case, the effect of high PEEP application on ventilation and patient outcomes is unclear.
In this study, PEEP values and mechanical power values applied during ventilation in patients who will be operated under laparoscopic surgery will be monitored observationally and the PEEP/MP relationship will be examined in terms of patient oxygenation.
- Being tested
- Mechanical Ventilation (MV) with Low PEEP, Mechanical Ventilation (MV) with Optimum PEEP
- Keywords
- Mechanical Power, Optimum PEEP, Laparoscopic abdominal surgery, mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Ventilation (MV) with Low PEEPOther
Mechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and 5cmH2o PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded.
Mechanical Ventilation (MV) with Optimum PEEPOther
Mechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and optimum PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded.
The optimum PEEP will be adjusted by titrating to the highest compliance with the open lung strategy.
| Study group | Role | What they receive |
|---|---|---|
| Group L | After the study group patients were informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the randomly grouped patients after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to the groups they are in. Group L patients will be applied standard 5 cmH2O PEEP after anesthesia induction.
The ventilation parameters and vital signs obtained will be recorded, and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume controlled patients. The groups will be compared for power hemodynamic values and blood gas for oxygenation. Receives: Other: Mechanical Ventilation (MV) with Low PEEP | |
| Group O | After the study group patients are informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the patients randomly grouped after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to their groups. Optimum PEEP will be applied to Group O patients after anesthesia induction, with the highest compliance values.
The ventilation parameters and vital signs obtained will be recorded and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume-controlled patients. The groups will be compared in terms of power hemodynamic values and blood gas for oxygenation. Receives: Other: Mechanical Ventilation (MV) with Optimum PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical power value in optimum PEEP
The primary aim of this study is to calculate the mechanical power values (in Joule/min) applied during ventilation among the optimum positive expiratory pressure values in patients undergoing laparoscopic surgery are higher than in patients applied low PEEP.
Measured: During the intraoperative period laparoscopic surgery
Secondary outcomes (1)
Effect of high mechanical power on oxygenation in blood gases
The effect of high mechanical power on oxygenation (Po2 in arterial blood gas analysis) in blood gases; to compare the calculated mechanical power values and partial oxygen pressures in perioperative blood gases between the groups.
Measured: During the intraoperative period laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start12 Sep 2024
- Primary completion5 Oct 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Ahmet Yuksek, Md, Study chair, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625099
- Sponsor's protocol ID
- 2024-68
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study patients belong to Kocaeli City Hospital and it is forbidden to share them.
Publications
Jo YY, Chang YJ, Lee D, Kim YB, Jung J, Kwak HJ. Comparisons of Mechanical Power and Respiratory Mechanics in Pressure-Controlled Ventilation and Volume-Controlled Ventilation during Laparoscopic Cholecystectomy in Elderly Patients. J Pers Med. 2023 Jan 23;13(2):201. doi: 10.3390/jpm13020201.
PubMed 36836435Pozzi T, Coppola S, Catozzi G, Colombo A, Chioccola M, Duscio E, Di Marco F, Chiumello D. Mechanical power during robotic-assisted laparoscopic prostatectomy: an observational study. J Clin Monit Comput. 2024 Oct;38(5):1135-1143. doi: 10.1007/s10877-024-01170-1. Epub 2024 Jun 17.
PubMed 38884875Romitti F, Busana M, Palumbo MM, Bonifazi M, Giosa L, Vassalli F, Gatta A, Collino F, Steinberg I, Gattarello S, Lazzari S, Palermo P, Nasr A, Gersmann AK, Richter A, Herrmann P, Moerer O, Saager L, Camporota L, Marini JJ, Quintel M, Meissner K, Gattinoni L. Mechanical power thresholds during mechanical ventilation: An experimental study. Physiol Rep. 2022 Mar;10(6):e15225. doi: 10.14814/phy2.15225.
PubMed 35340133Gattinoni 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 28701178Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Silva PL, Ball L, Rocco PRM, Pelosi P. Physiological and Pathophysiological Consequences of Mechanical Ventilation. Semin Respir Crit Care Med. 2022 Jun;43(3):321-334. doi: 10.1055/s-0042-1744447. Epub 2022 Apr 19.
PubMed 35439832Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Positive Expiratory Pressure Levels on Patient Oxygenation and Mechanical Power Values in Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT06625099
- Acronym / sponsor ID
- 2024-68
- Keywords
- Mechanical Power, Optimum PEEP, Laparoscopic abdominal surgery, mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 3 Oct 2024 (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.
The aim of this study is to compare the effects of standard and optimum positive end expiratory pressures on mechanical power during laparoscopic surgeries.
Detailed description
Perioperative pulmonary complications and ventilator-associated lung injury are challenging issues for anesthesiologists, especially after laparoscopic surgeries. An increasing number of studies suggest lung protective ventilation (LPV) strategies in these patients. It is recommended that patients\&; driving pressure be kept low during LPV and positive expiratory pressure (PEEP) be applied to keep the lungs open. However, high PEEP values cannot be adequately applied in laparoscopic surgeries to reduce the restrictive peak pressure for LPV. In laparoscopic surgeries, the patients position and increased intra-abdominal pressure create pressure on the lungs. However, when the applied positive pressure ventilation is insufficient in patients, it can cause atelectasis, and when it is excessive, it can cause barotrauma or volutrauma. The threshold values determined for all these possible complications during LPV should be evaluated together.
Gattinoni and colleagues (2016) explained the effect of mechanical ventilation on the lungs through a work/time formula and formulated the energy used during this work. The applied energy is spent on opening the lungs and ventilation, while the excess is consumed due to heat and resistance in the respiratory tract. The unit of this energy can be formulated in a simplified way as joule/second. The mechanical power formula makes it easier to follow by providing a single parameter instead of different threshold values for barotrauma, volutrauma and atelectrauma for the lungs. Studies have shown that applying energy over 12.6 joules is associated with lung damage. On the other hand, the relationship between the optimum mechanical power (MP) value during ventilation and low and high PEEP is not yet fully known.
In laparoscopic surgeries, high PEEP application may help keep the lungs open and increase ventilation, but it may cause higher mechanical power application. In this case, the effect of high PEEP application on ventilation and patient outcomes is unclear.
In this study, PEEP values and mechanical power values applied during ventilation in patients who will be operated under laparoscopic surgery will be monitored observationally and the PEEP/MP relationship will be examined in terms of patient oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | – | Other: Mechanical Ventilation (MV) with Low PEEPAfter the study group patients were informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the randomly grouped patients after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to the groups they are in. Group L patients will be applied standard 5 cmH2O PEEP after anesthesia induction. The ventilation parameters and vital signs obtained will be recorded, and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume controlled patients. The groups will be compared for power hemodynamic values and blood gas for oxygenation. |
| Group O | – | Other: Mechanical Ventilation (MV) with Optimum PEEPAfter the study group patients are informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the patients randomly grouped after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to their groups. Optimum PEEP will be applied to Group O patients after anesthesia induction, with the highest compliance values. The ventilation parameters and vital signs obtained will be recorded and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume-controlled patients. The groups will be compared in terms of power hemodynamic values and blood gas for oxygenation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo laparoscopic cholecystectomy in the operating rooms of Kocaeli City Hospital will constitute the study universe.
Key inclusion criteria (7 listed)
- within the appropriate age range
- agreeing to participate in the study
- again receiving lancetesthesia
- volume controlled ventilation
- no known lung disease
Key exclusion criteria (5 listed)
- . Patients who do not want to be included in the study will not be included
- Patients with intraoperative deep hypotension (mean arterial pressure \<50) will be excluded.
- Those who develop intraoperative hypothermia or have other anesthesia complications will be excluded.
- Patients who will not be extubated postoperatively will be excluded from the study.
- Those with neurological diseases or those using psychiatric medications will also be excluded from the study.
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 |
|---|---|---|
| Mechanical Ventilation (MV) with Low PEEPMechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and 5cmH2o PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded. | Other | Group L |
| Mechanical Ventilation (MV) with Optimum PEEPMechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and optimum PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded. The optimum PEEP will be adjusted by titrating to the highest compliance with the open lung strategy. | Other | Group O |
Primary outcome
Mechanical power value in optimum PEEP
Time frame: During the intraoperative period laparoscopic surgery
The primary aim of this study is to calculate the mechanical power values (in Joule/min) applied during ventilation among the optimum positive expiratory pressure values in patients undergoing laparoscopic surgery are higher than in patients applied low PEEP.
1 secondary outcome
Effect of high mechanical power on oxygenation in blood gases
Time frame: During the intraoperative period laparoscopic surgery
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 24 Nov 2025.
- Background: PubMed 36836435Jo YY, Chang YJ, Lee D, Kim YB, Jung J, Kwak HJ. Comparisons of Mechanical Power and Respiratory Mechanics in Pressure-Controlled Ventilation and Volume-Controlled Ventilation during Laparoscopic Cholecystectomy in Elderly Patients. J Pers Med. 2023 Jan 23;13(2):201. doi: 10.3390/jpm13020201.
- Background: PubMed 38884875Pozzi T, Coppola S, Catozzi G, Colombo A, Chioccola M, Duscio E, Di Marco F, Chiumello D. Mechanical power during robotic-assisted laparoscopic prostatectomy: an observational study. J Clin Monit Comput. 2024 Oct;38(5):1135-1143. doi: 10.1007/s10877-024-01170-1. Epub 2024 Jun 17.
- Background: PubMed 35340133Romitti F, Busana M, Palumbo MM, Bonifazi M, Giosa L, Vassalli F, Gatta A, Collino F, Steinberg I, Gattarello S, Lazzari S, Palermo P, Nasr A, Gersmann AK, Richter A, Herrmann P, Moerer O, Saager L, Camporota L, Marini JJ, Quintel M, Meissner K, Gattinoni L. Mechanical power thresholds during mechanical ventilation: An experimental study. Physiol Rep. 2022 Mar;10(6):e15225. doi: 10.14814/phy2.15225.
- 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 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 35439832Silva PL, Ball L, Rocco PRM, Pelosi P. Physiological and Pathophysiological Consequences of Mechanical Ventilation. Semin Respir Crit Care Med. 2022 Jun;43(3):321-334. doi: 10.1055/s-0042-1744447. Epub 2022 Apr 19.
- Background: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Individual participant dataSharing planned: No. The data of the study patients belong to Kocaeli City Hospital and it is forbidden to share them.
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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.
Ahmet Yuksek, Md study chair
Kocaeli City Hospital
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 Mechanical Ventilation and Mechanical Power, run by Kocaeli City 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 7 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 24 Nov 2025. 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?
Mechanical power value in optimum PEEP (time frame: During the intraoperative period laparoscopic 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 NCT06625099, which also lists 7 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 24 Nov 2025.