Effect of Optimized PEEP on Mechanical Ventilation During Robot Assisted Laparoscopic Prostatectomy

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: conventional PEEP; Device: optimized PEEP

• Registration Number: NCT05669443
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-30
• Study Start: 2023-04-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-11-10
• Study Completion: 2024-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

1. 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital,
2. ASA-PS (American Society of Anesthesiology Body Rating) I-IlI,
3. Patients with a BMI of 35 kg/m2 or less

Exclusion Criteria

1. Patients with lung disease
2. BMI >35kg/m2
3. Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease)
4. patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional PEEP	conventional PEEP	Apply of PEEP 5
optimized PEEP	optimized PEEP	Apply of optimized PEEP derived using EIT (airtom®)

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2	end of surgery (before extubation)	PaO2/FiO2 is the ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.

Secondary Outcome Measures

Name	Time	Method
ROI (region of interests)	15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)	region of interest using EIT
inhomogeneity index	15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)	inhomogeneity index : this index calculated from tidal EIT images representing the difference in impedance between the end of inspiration and the end of expiration.
total amount of fluid administered during surgery	end or surgery
PaO2/FiO2	15 minutes after intubation, 1 hour after pnemoperitoneum	partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.
total dose of vasopressor administered during surgery	end of surgery
length of hospitalization after surgery	1 month after surgery

Trial Locations

Locations (1)

Gangnam Severacne Hospital Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of