Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.

Official Title
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The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial

Conditions
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Atelectasis, Postoperative Pulmonary

Intervention / Treatment
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* Procedure: Titrated PEEP based on driving pressure
* Procedure: Conventional PEEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position Exclusion Criteria: American Society of Anesthesiologists physical status IV or more Severe cardiovascular disease Severe chronic obstructive pulmonary disease, emphysema History of pneumothorax, bullae History of lung resection surgery Conversion to laparotomy Refusal to participate

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Driving pressure<br>The selected PEEP which makes the driving pressure lowest is applied during the operation. | Procedure: Titrated PEEP based on driving pressure<br>* Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.<br>|
| Active Comparator: Conventional<br>Conventional PEEP (5cmH2O) is applied. | Procedure: Conventional PEEP<br>* Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified lung ultrasound score | The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3. | 30 minutes after PACU administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified lung ultrasound score | The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3. | Intraoperative (at the end of operation before emergence) | 
| Incidence of intraoperative desaturation | Oxygen saturation by pulse oximetry< 95% | Intraoperative | 
| Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio | Partial pressure of arterial oxygen/fraction of inspired oxygen ratio | Intraoperative (30 minutes after designated PEEP applied) | 
| Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio | Partial pressure of arterial oxygen/fraction of inspired oxygen ratio | 30 minutes after PACU administration | 
| Postoperative pulmonary complications | Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia | After operation  postoperative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Driving pressure, Positive end-expiratory pressure, Lung ultrasound