- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06625099
Investigation of the Optimum PEEP Mechanical Power Relationship
Comparison of the Effects of Different Positive Expiratory Pressure Levels on Patient Oxygenation and Mechanical Power Values in Laparoscopic Surgeries
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Izmıt
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Kocaeli, Izmıt, Turkey (Türkiye), 41100
- Kocaeli City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- . 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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During the intraoperative period laparoscopic surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of high mechanical power on oxygenation in blood gases
Time Frame: During the intraoperative period laparoscopic surgery
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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.
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During the intraoperative period laparoscopic surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmet Yuksek, Md, Kocaeli City Hospital
Publications and helpful links
General Publications
- Gattinoni 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.
- 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.
- Silva 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.
- Paudel 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.
- 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.
- Pozzi 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.
- Romitti 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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