Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery
NCT ID: NCT05554536
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-02-22
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single arm intervention
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).
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%).
Interventions
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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%).
Eligibility Criteria
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Inclusion Criteria
* Body mass index \> 30 kg/m2
* Major surgery
* Predicted duration of surgery \> 2 hours
* Predicted presence of invasive arterial pressure monitoring
Exclusion Criteria
* Refuse to participate from patient
* presence of Implantable cardiac device or pacemaker
* thoracic wounds
* thoracic surgery
18 Years
80 Years
ALL
No
Sponsors
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Università degli Studi di Ferrara
OTHER
Responsible Party
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Savino Spadaro
Clinical Professor
Principal Investigators
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Savino Spadaro, MD, PhD
Role: STUDY_DIRECTOR
Università degli Studi di Ferrara
Locations
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Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Scaramuzzo G, Priani P, Ferrara P, Verri M, Montanaro F, La Rosa R, Cammarota G, Volta CA, Spadaro S. Longitudinal changes of electrical impedance tomography-based best PEEP in obese patients undergoing laparoscopic surgery: A prospective physiological study. Anaesth Crit Care Pain Med. 2025 Jun 13;44(5):101569. doi: 10.1016/j.accpm.2025.101569. Online ahead of print.
Other Identifiers
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OBESE-EIT
Identifier Type: -
Identifier Source: org_study_id
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