Clinical trial NCT06625099: Investigation of the Optimum PEEP Mechanical Power Relationship
Official title: Comparison of the Effects of Different Positive Expiratory Pressure Levels on Patient Oxygenation and Mechanical Power Values in Laparoscopic Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilation
Mechanical Power
Optimum PEEP
Laparoscopic Abdominal Surgery
Keywords: Mechanical Power
Optimum PEEP
Laparoscopic abdominal surgery
mechanical Ventilation
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo laparoscopic cholecystectomy in the operating rooms of Kocaeli City Hospital will constitute the study universe.

Brief 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.

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.

Eligibility criteria: 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 \&lt;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.

Primary outcomes:
measure: Mechanical power value in optimum PEEP
timeFrame: During the intraoperative period laparoscopic surgery
Secondary outcomes:
measure: Effect of high mechanical power on oxygenation in blood gases
timeFrame: During the intraoperative period laparoscopic surgery
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
state: Izmıt
Study officials:
affiliation: Kocaeli City Hospital
name: Ahmet Yuksek, Md
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.