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

Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: conventional PEEP; Device: optimized PEEP

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chul-Ho Chang; Phone Number: 82-2-2019-4601; Email: ANEZZANG@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severacne Hospital Yonsei University College of Medicine
    • Contact: Jiwon Lee; Phone Number: 82-2-2019-4601; Email: BELIEF705@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional PEEP; Apply of PEEP 5	Device: conventional PEEP; Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.
Active Comparator: optimized PEEP; Apply of optimized PEEP derived using EIT (airtom®)	Device: optimized PEEP; Immediately after induction of anesthesia, the patient remains unapplied to PEEP. After pneumoperitoneum + Trendelenburg posture, an appropriate PEEP value is derived using electrical impedance tomography (airtom®). And then derived value ( = optimized PEEP value) is applied until the end of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	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.	end of surgery (before extubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	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.	15 minutes after intubation, 1 hour after pnemoperitoneum
ROI (region of interests)	region of interest using EIT	15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
inhomogeneity index	inhomogeneity index : this index calculated from tidal EIT images representing the difference in impedance between the end of inspiration and the end of expiration.	15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
total amount of fluid administered during surgery		end or surgery
total dose of vasopressor administered during surgery		end of surgery
length of hospitalization after surgery		1 month after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): November 10, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 3-2022-0361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No