Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation Pressure High; Intraoperative Respiratory Injury; Obesity
• Interventions: Procedure: PEEP titration trial

• Registration Number: NCT05554536
• Lead Sponsor: Università degli Studi di Ferrara

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.

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 Timeline

• Study Start: 2022-02-22
• Status Verified: 2022-09
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm intervention	PEEP titration trial	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).

Primary Outcome Measures

Name	Time	Method
Best Positive end-expiratory pressure - Laparoscopy variability	Difference between the best PEEP after anesthesia induction and during pneumoperitoneum	The primary outcome will be the best PEEP found using the PEEP titration trial.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy