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Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05554536
Acronym
OBESE-EIT
Enrollment
30
Registered
2022-09-26
Start date
2022-02-22
Completion date
2023-06-30
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Mechanical Ventilation Pressure High, Intraoperative Respiratory Injury

Keywords

EIT, Obesity, Laparoscopy

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.

Interventions

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%).

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Best Positive end-expiratory pressure - Laparoscopy variabilityDifference between the best PEEP after anesthesia induction and during pneumoperitoneumThe primary outcome will be the best PEEP found using the PEEP titration trial.

Secondary

MeasureTime frameDescription
Best Positive end-expiratory pressure - EIT variabilityAfter anesthesia induction, during pneumoperitoneum, end of surgerySecondary outcome will be to compare the different values of best PEEP provided by several parameters of EIT to evaluate if the overlap.

Countries

Italy

Contacts

Primary ContactSavino Spadaro, MD, PhD
savino.spadaro@unife.it+393894841243
Backup ContactGaetano Scaramuzzo, MD
gaetano.scaramuzzo@unife.it+393275356790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026