Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery

NCT05554536 | Unknown

• 1 other identifier: OBESE-EIT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate what is the impact of laparoscopy and Trendelenburg position on lung regional ventilation distribution in obese patients, focusing on the differences between the different phases of surgery.

Conditions

Obesity; Mechanical Ventilation Pressure High; Intraoperative Respiratory Injury

Keywords

EIT; Obesity; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Best Positive end-expiratory pressure - Laparoscopy variability

  The primary outcome will be the best PEEP found using the PEEP titration trial.

  Difference between the best PEEP after anesthesia induction and during pneumoperitoneum

Secondary Outcomes (1)

• Best Positive end-expiratory pressure - EIT variability

  After anesthesia induction, during pneumoperitoneum, end of surgery

Study Arms (1)

Single arm intervention

OTHER

All patients will undergo a PEEP titration trial in each surgery step (before pneumoperitoneum, during pneumoperitoneum, after pneumoperitoneum). The PEEP titration trial will be done in steps of 2 cmH2O, starting from clinical PEEP 16 cmH2O and ending to PEEP 6 cmH2O. Each PEEP level will be kept for 2 minutes. The PEEP titration trial will be stopped in case of haemodynamic instability or severe desaturation (Spo2 \< 92%). Each PEEP titration trial will be recorded using Electrical impedance tomography (EIT).

Procedure: PEEP titration trial

Interventions

PEEP titration trial PROCEDURE

PEEP trial, starting from clinical PEEP 16 cmH2O and ending at PEEP 6 cmH2O. The PEEP trial will be stopped for haemodynamic instability (defined as arterial pressure \< 80 mmHg and /or heart rate \> 150 bpm) or desaturation (defined as SpO2 \< 92%).

Single arm intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-90 years
• Body mass index \> 30 kg/m2
• Major surgery
• Predicted duration of surgery \> 2 hours
• Predicted presence of invasive arterial pressure monitoring

You may not qualify if:

• emergency surgery
• Refuse to participate from patient
• presence of Implantable cardiac device or pacemaker
• thoracic wounds
• thoracic surgery

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

RECRUITING

Related Publications (5)

• Erlandsson K, Odenstedt H, Lundin S, Stenqvist O. Positive end-expiratory pressure optimization using electric impedance tomography in morbidly obese patients during laparoscopic gastric bypass surgery. Acta Anaesthesiol Scand. 2006 Aug;50(7):833-9. doi: 10.1111/j.1399-6576.2006.01079.x.

  PMID: 16879466 BACKGROUND

• Zhu C, Yao JW, An LX, Bai YF, Li WJ. Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial. Trials. 2020 Jul 6;21(1):618. doi: 10.1186/s13063-020-04565-y.

  PMID: 32631414 BACKGROUND

• Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7.

  PMID: 31390977 BACKGROUND

• de Castro Martins T, Sato AK, de Moura FS, de Camargo EDLB, Silva OL, Santos TBR, Zhao Z, Moeller K, Amato MBP, Mueller JL, Lima RG, de Sales Guerra Tsuzuki M. A Review of Electrical Impedance Tomography in Lung Applications: Theory and Algorithms for Absolute Images. Annu Rev Control. 2019;48:442-471. doi: 10.1016/j.arcontrol.2019.05.002. Epub 2019 May 17.

  PMID: 31983885 BACKGROUND

• Scaramuzzo G, Priani P, Ferrara P, Verri M, Montanaro F, La Rosa R, Cammarota G, Volta CA, Spadaro S. Longitudinal changes of electrical impedance tomography-based best PEEP in obese patients undergoing laparoscopic surgery: A prospective physiological study. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101569. doi: 10.1016/j.accpm.2025.101569. Epub 2025 Jun 13.

  PMID: 40518045 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Savino Spadaro, MD, PhD

  Università degli Studi di Ferrara

  STUDY DIRECTOR

Central Study Contacts

Savino Spadaro, MD, PhD

CONTACT

+393894841243; savino.spadaro@unife.it

Gaetano Scaramuzzo, MD

CONTACT

+393275356790; gaetano.scaramuzzo@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: February 22, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)