Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery (OBESE-EIT)

Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery Using Electrical Impedance Tomography

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Mechanical Ventilation Pressure High; Intraoperative Respiratory Injury
• Intervention / Treatment: Procedure: PEEP titration trial

Detailed Description

Electrical impedance tomography (EIT) is a non invasive monitoring technique that allows to evaluate the regional distribution of ventilation. EIT has been used in different contexts, such as acute respiratory failure or intraoperative ventilation settings. Obesity, by increasing intrabdominal pressure, may reduce functional residual capacity after anesthesia and therefore require a more aggressive intraoperative ventilatory setting. In addition, laparoscopy, by increasing the volume of the abdomen, further pushes the diaphragm and increase the probability of lung collapse.

The aim of the current study is to describe the effect of 1) anesthesia and of 2) laparoscopy and trendelenburg position on regional ventilation distribution. Moreover, the investigators will evaluate if the best ventilatory parameters set after anesthesia induction are confirmed also when the condition changes (i.e. during pneumoperitoneum and trendellenburg).

Finally, the investigators will explore if the different parameters which can be provided by EIT agree in suggesting the best level of positive-end expiratory pressure in both moments of surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savino Spadaro, MD, PhD; Phone Number: +393894841243; Email: savino.spadaro@unife.it
• Study Contact Backup: Name: Gaetano Scaramuzzo, MD; Phone Number: +393275356790; Email: gaetano.scaramuzzo@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Recruiting
    • Azienda Ospedaliero Universitaria Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single arm intervention; 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; 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Positive end-expiratory pressure - EIT variability	Secondary outcome will be to compare the different values of best PEEP provided by several parameters of EIT to evaluate if the overlap.	After anesthesia induction, during pneumoperitoneum, end of surgery

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Investigators: Study Director: Savino Spadaro, MD, PhD, Università degli Studi di Ferrara

Publications and helpful links

General Publications

• 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. Erratum In: BMC Anesthesiol. 2019 Sep 4;19(1):172.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Laparoscopy; EIT
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: OBESE-EIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No