The Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Laparoscopic Cholecystectomy

Ventilator-induced Lung Injury Clinical Trial

Official title:

Evaluation of the Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Cases Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05859906
• Other study ID #: 2023/104
• Status: Not yet recruiting
• Start date: May 15, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: May 2023
• Source: TC Erciyes University
• Contact: Ayse Ülgey, MD
• Phone: 05378201751
• Email: aulgey[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg and 14 mmHg pressures in our operating room, and the preferred pressure value is; It is determined by the surgical team to be the most appropriate value for the patient and the operation. Both pressure values applied to the patients intraoperatively are within safe ranges. The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI). To prevent ventilator-associated lung injury, it requires the mechanical ventilator to be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient. In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality, higher hospital stay and higher ICU follow-up requirement. The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.

Description:

In laparoscopic surgeries; a trocar is inserted through a small incision and an intervention is made into the peritoneal cavity. Approximately 3-4 liters of carbon dioxide (CO2) insufflation (inflating the abdominal cavity with carbon dioxide gas) is applied and the intra-abdominal pressure is adjusted to 10-20 mmHg. Intra-abdominal pressure is continuously measured by pressure monitoring, which is routinely performed during laparoscopic procedures. The applied intra-abdominal pressure is determined by the surgical team and the most optimal value that creates pneumoperitoneum for the patient is preferred. Abdominal compartment syndrome can be seen due to abdominal hypertension at intra-abdominal pressure values above 20 mmHg. Both pressure values aimed to be applied in this study are applied in laparoscopic cholecystectomy operations and do not cause any harm to the patient and their superiority to each other has not been determined. Laparoscopic cholecystectomy operation is routinely performed with 12 mmHg or 14 mmHg pressures in our operating room. Both pressure values applied to the patients intraoperatively are within safe ranges. The mechanical power of ventilation (MP) is the amount of energy transferred per unit time from the mechanical ventilator to the respiratory system. Although this energy is mainly used to overcome airway resistance and respiratory system compliance, some of it directly affects the lung tissue, potentially causing ventilator induced lung injury (VILI). MP is a summary variable that includes several components, including tidal volume (VT ), peak pressure (Ppeak), driving pressure (Driving Pressure, ΔP), and respiratory rate (RR). These components; requires that the mechanical ventilator be adjusted so that the least amount of energy is transferred to the respiratory system per unit time for each patient in order to prevent ventilator-associated lung injury. In the researches; a relationship between mechanical power (MP) and complications such as ventilator-associated lung injury (VILI) and acute respiratory distress syndrome (ARDS) has been found. The findings suggest that the mechanical force applied to the lungs should be reduced during intraoperative ventilation in patients undergoing major surgery. In adult patients undergoing general anesthesia during major surgical operations, higher patient exposure to ventilation as measured by higher mechanical power; it has been shown that it is associated with an increased risk of postoperative pulmonary complications and acute respiratory failure in the first 7 days of the postoperative period. In the results obtained in the published studies; increased mechanical strength has been associated with increased in-hospital mortality and higher hospital stay and higher ICU follow-up requirement. The aim of this study is to investigate the effect of two different intra-operative intra-abdominal pressure levels applied to patients who underwent laparoscopic cholecystectomy under general anesthesia on 'Mechanical Power (MP)'.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with ASA 1-2
• The patient's willingness to participate in the study voluntarily

Exclusion Criteria:

• Patients with ASA 3-4
• Patients with lung disease such as pneumonia, COPD attack before the operation
• Patients undergoing other surgical procedures or anesthesia technique
• Pregnant patients
• Patients with morbid obesity
• Unstable patients such as uncontrolled hypertension, decompensated heart disease
• The patient's intraoperative intra-abdominal pressure value is operated with a difference from the pressure determined due to optimal surgical conditions or the patient's lungs do not tolerate it, or switching to open surgery (laparotomy) for any reason.

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury

Intervention

Other:
• mechanical power measurement
Mechanical power values of the patients; Before insufflation (baseline value), 0 min after insufflation, 15th min after insufflation, 30 minutes after insufflation, 45th minute after insufflation (if insufflation continues), 60th minute after insufflation (if insufflation continues), Intraoperative after insufflation It will be measured with the following formula in the specified periods. MP = 0.098 x minute ventilation x [Peak inspiratory pressure - 0.5 x (Plateau pressure - Positive end-expiratory pressure)]

Locations

Country	Name	City	State
Turkey	Ayse Ülgey	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
Ayse Ulgey

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056. — View 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. — View Citation

Karalapillai D, Weinberg L, Neto A S, Peyton P, Ellard L, Hu R, Pearce B, Tan CO, Story D, O'Donnell M, Hamilton P, Oughton C, Galtieri J, Wilson A, Eastwood G, Bellomo R, Jones DA. Intra-operative ventilator mechanical power as a predictor of postoperative pulmonary complications in surgical patients: A secondary analysis of a randomised clinical trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):67-74. doi: 10.1097/EJA.0000000000001601. — View Citation

Protti A, Andreis DT, Monti M, Santini A, Sparacino CC, Langer T, Votta E, Gatti S, Lombardi L, Leopardi O, Masson S, Cressoni M, Gattinoni L. Lung stress and strain during mechanical ventilation: any difference between statics and dynamics? Crit Care Med. 2013 Apr;41(4):1046-55. doi: 10.1097/CCM.0b013e31827417a6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilator-induced lung injury (barotrauma)	mechanical power values measured during operation will be recorded	during the operation