Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery (OBESE-EIT)
Primary Purpose
Obesity, Mechanical Ventilation Pressure High, Intraoperative Respiratory Injury
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PEEP titration trial
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring EIT, Obesity, Laparoscopy
Eligibility Criteria
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
Sites / Locations
- Azienda Ospedaliero Universitaria Sant'AnnaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm intervention
Arm Description
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).
Outcomes
Primary Outcome Measures
Best Positive end-expiratory pressure - Laparoscopy variability
The primary outcome will be the best PEEP found using the PEEP titration trial.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05554536
First Posted
September 21, 2022
Last Updated
September 23, 2022
Sponsor
Università degli Studi di Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT05554536
Brief Title
Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery
Acronym
OBESE-EIT
Official Title
Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery Using Electrical Impedance Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Mechanical Ventilation Pressure High, Intraoperative Respiratory Injury
Keywords
EIT, Obesity, Laparoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm intervention
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
PEEP titration trial
Intervention Description
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%).
Primary Outcome Measure Information:
Title
Best Positive end-expiratory pressure - Laparoscopy variability
Description
The primary outcome will be the best PEEP found using the PEEP titration trial.
Time Frame
Difference between the best PEEP after anesthesia induction and during pneumoperitoneum
Secondary Outcome Measure Information:
Title
Best Positive end-expiratory pressure - EIT variability
Description
Secondary outcome will be to compare the different values of best PEEP provided by several parameters of EIT to evaluate if the overlap.
Time Frame
After anesthesia induction, during pneumoperitoneum, end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Savino Spadaro, MD, PhD
Phone
+393894841243
Email
savino.spadaro@unife.it
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Scaramuzzo, MD
Phone
+393275356790
Email
gaetano.scaramuzzo@unife.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savino Spadaro, MD, PhD
Organizational Affiliation
Università degli Studi di Ferrara
Official's Role
Study Director
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Sant'Anna
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savino Spadaro, MD
Phone
+390532239780
Email
savinospadaro@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16879466
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. doi: 10.1111/j.1399-6576.2006.01079.x.
Results Reference
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PubMed Identifier
32631414
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.
Results Reference
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PubMed Identifier
31390977
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. Erratum In: BMC Anesthesiol. 2019 Sep 4;19(1):172.
Results Reference
background
PubMed Identifier
31983885
Citation
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.
Results Reference
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Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery
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