OBESE-EIT: Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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). |
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%).
|
Outcome Measures
Primary Outcome Measures
- Best Positive end-expiratory pressure - Laparoscopy variability [Difference between the best PEEP after anesthesia induction and during pneumoperitoneum]
The primary outcome will be the best PEEP found using the PEEP titration trial.
Secondary Outcome Measures
- Best Positive end-expiratory pressure - EIT variability [After anesthesia induction, during pneumoperitoneum, end of surgery]
Secondary outcome will be to compare the different values of best PEEP provided by several parameters of EIT to evaluate if the overlap.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 18-90 years
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Body mass index > 30 kg/m2
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Major surgery
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Predicted duration of surgery > 2 hours
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Predicted presence of invasive arterial pressure monitoring
Exclusion Criteria:
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emergency surgery
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Refuse to participate from patient
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presence of Implantable cardiac device or pacemaker
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thoracic wounds
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thoracic surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliero Universitaria Sant'Anna | Ferrara | Italy | 44121 |
Sponsors and Collaborators
- Università degli Studi di Ferrara
Investigators
- Study Director: Savino Spadaro, MD, PhD, Università degli Studi di Ferrara
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- OBESE-EIT