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

NCT05859906 | Unknown

• 1 other identifier: 2023/104
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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)'.

Conditions

Ventilator-induced Lung Injury

Keywords

Mechanical power; laparoscopic surgery; Ventilator-induced lung injury

Outcome Measures

Primary Outcomes (1)

• ventilator-induced lung injury (barotrauma)

  mechanical power values measured during operation will be recorded

  during the operation

Study Arms (2)

Group 12 mmHg

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

Other: mechanical power measurement

Group 14 mmHg

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

Other: mechanical power measurement

Interventions

mechanical power measurement 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 12 mmHg; Group 14 mmHg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 patients who will be operated for laparoscopic cholecystectomy at Erciyes University between May 2023 and Oct 2023 will be included in our study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayse Ulgey: lead

Study Sites (1)

Ayşe Ülgey

Kayseri, Talas, 38100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23385096 BACKGROUND

• 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.

  PMID: 26872367 BACKGROUND

• 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.

  PMID: 27620287 BACKGROUND

• 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.

  PMID: 34560687 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ayşe Ülgey, MD

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Ayşe Ülgey, MD

CONTACT

05378201751; aulgey@erciyes.edu.tr

Gamze Talih, MD

CONTACT

05447604780; gamzetalih@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: May 15, 2023
• Primary Completion: August 15, 2023
• Study Completion: October 15, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data accept requests will be reviewed by an external independent Review Panel. Requesters will be required to sign a Data Access Agreement

Locations

TU (1)