End-expiratory Pressure During Laparoscopic Surgery in the Trendelenburg Position by Electrical Impedance Tomography

NCT06481124 | Completed

• 1 other identifier: CP-EIT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumoperitoneum (PNP) and the position of the patient required for laparoscopic surgery lead to pathophysiological changes that complicate anesthesia. PNP is characterized by an increased intra-abdominal pressure (IAP), the cranial displacement of the diaphragm that can lead to the formation of intraoperative atelectasis and decrease end-expiratory lung volume (EELV). At the same time, PNP can reduce respiratory system compliance by 30-50% in healthy patients. During elective abdominal surgery under general anesthesia, atelectasis forms in almost 90% of patients and can become a focus of postoperative pneumonia. The negative effect of PNP is more prominent in Trendelenburg position. And one of the methods to avoid the effects of PNP and Trendelenburg position on lung tissue is to apply positive end-expiratory pressure (PEEP). PEEP is acknowledged as a component of lung protective ventilation (LPV) along with low tidal volume (TV) 6-8 ml/kg. On the other hand, excessive PEEP can lead to the overdistension of lung tissue and cause volutrauma and hemodynamic instability. It is necessary to use sufficient PEEP to minimize atelectasis, improve respiratory biomechanics and maintain oxygenation. Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels. The study aimed to select optimum PEEP level based on optimum ventilation-to-perfusion match based on electrical impedance tomography measurements.

Conditions

Pneumoperitoneum; Trendelenburg Position; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• Optimum positive end-expiratory pressure level by compliance win

  Positive end-expiratory pressure level selected by maximal compliance win measured by electrical impedance tomography

  40 minutes

• Optimum positive end-expiratory pressure level by heart-lung index

  Positive end-expiratory pressure level selected by maximal heart-lung index measured by electrical impedance tomography

  40 minutes

Secondary Outcomes (10)

• Compliance win

  3 minutes

• Compliance loss

  3 minutes

• Global inhomogeneity index

  3 minutes

• Regional ventilation delay

  3 minutes

• Lung-heart index

  3 minutes

Interventions

electrical impedance tomography DEVICE

Measurement of ventilation and perfusion during mechanical ventilation with different positive end-expiratory pressure by electrical impedance tomography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Gynecological surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective gynecological operations in conditions of carboxyperitoneum with Trendelenburg position

You may qualify if:

• Patients who undergo gynecological surgery under conditions of carboxyperitoneum in the Trendelenburg position.

You may not qualify if:

• Pregnancy,
• Hypoxemia before surgery (SpO2 \< 94%),
• body mass index more than 35 kg/m2,
• Unstable hemodynamics and/or life-threatening arrhythmia,
• Primary or secondary lung diseases (COPD, interstitial lung diseases, metastatic lung disease)
• Presence of an implantable pacemaker and/or defibrillator
• Chronic diseases in the stage of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, chronic heart failure).

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Clinical Hospital 4, Sechenov University

Moscow, 119048, Russia

Location

Related Publications (5)

• Andersson LE, Baath M, Thorne A, Aspelin P, Odeberg-Wernerman S. Effect of carbon dioxide pneumoperitoneum on development of atelectasis during anesthesia, examined by spiral computed tomography. Anesthesiology. 2005 Feb;102(2):293-9. doi: 10.1097/00000542-200502000-00009.

  PMID: 15681942 BACKGROUND

• Loring SH, Behazin N, Novero A, Novack V, Jones SB, O'Donnell CR, Talmor DS. Respiratory mechanical effects of surgical pneumoperitoneum in humans. J Appl Physiol (1985). 2014 Nov 1;117(9):1074-9. doi: 10.1152/japplphysiol.00552.2014. Epub 2014 Sep 11.

  PMID: 25213641 BACKGROUND

• Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.

  PMID: 24919591 BACKGROUND

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

  PMID: 24283226 BACKGROUND

• Fahy BG, Barnas GM, Nagle SE, Flowers JL, Njoku MJ, Agarwal M. Changes in lung and chest wall properties with abdominal insufflation of carbon dioxide are immediately reversible. Anesth Analg. 1996 Mar;82(3):501-5. doi: 10.1097/00000539-199603000-00013.

  PMID: 8623951 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Andrey I Yaroshetskiy, MD, PhD, ScD

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 1, 2024
• Study Start: June 24, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-06

Locations

RU (1)