Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05554536
Other study ID # OBESE-EIT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2