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

NCT ID: NCT05859906

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-10-15

Brief 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)'.

Detailed 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)'.

Conditions

Ventilator-induced Lung Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 12 mmHg

All patients in this group will be operated with an insufflation pressure of 12 mmHg during laparoscopic cholecystectomy surgery.

mechanical power measurement

Intervention Type: OTHER

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)]

Group 14 mmHg

All patients in this group will be operated with an insufflation pressure of 14 mmHg during laparoscopic cholecystectomy surgery.

mechanical power measurement

Intervention Type: OTHER

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)]

Interventions

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)]

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ayse Ulgey

OTHER

Sponsor Role: lead

Responsible Party

Ayse Ulgey

Professor Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ayşe Ülgey, MD

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

Ayşe Ülgey

Kayseri, Talas, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ayşe Ülgey, MD

Role: CONTACT

aulgey@erciyes.edu.tr

05378201751

Gamze Talih, MD

Role: CONTACT

gamzetalih@erciyes.edu.tr

05447604780

References

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.

Reference Type: BACKGROUND

PMID: 23385096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26872367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27620287 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34560687 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

2023/104

Identifier Type: -

Identifier Source: org_study_id