Investigation of the Optimum PEEP Mechanical Power Relationship

Recruiting

• Conditions: Mechanical Ventilation; Mechanical Power; Optimum PEEP; Laparoscopic Abdominal Surgery
• Interventions: Other: Mechanical Ventilation (MV) with Optimum PEEP; Other: Mechanical Ventilation (MV) with Low PEEP

• Registration Number: NCT06625099
• Lead Sponsor: Kocaeli City Hospital

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.

Study Timeline

• Study Start: 2024-09-12
• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group O	Mechanical Ventilation (MV) with Optimum PEEP	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.
Group L	Mechanical Ventilation (MV) with Low PEEP	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.

Primary Outcome Measures

Name	Time	Method
Mechanical power value in optimum PEEP	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.

Secondary Outcome Measures

Name	Time	Method
Effect of high mechanical power on oxygenation in blood gases	During the intraoperative period laparoscopic surgery	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.

Trial Locations

Locations (1)

Kocaeli City Hospital; 🇹🇷 Kocaeli, Izmıt, Turkey