Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery

Obesity Clinical Trial

— OBESE-EIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554536
• Other study ID #: OBESE-EIT
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Università degli Studi di Ferrara
• Contact: Savino Spadaro, MD, PhD
• Phone: +393894841243
• Email: savino.spadaro[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Pressure High
• Obesity

Intervention

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%).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (4)

de Castro Martins T, Sato AK, de Moura FS, de Camargo EDLB, Silva OL, Santos TBR, Zhao Z, Möeller 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. — View Citation

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. — View Citation

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. Review. Erratum in: BMC Anesthesiol. 2019 Sep 4;19(1):172. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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