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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional PEEP
optimized PEEP
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital, ASA-PS (American Society of Anesthesiology Body Rating) I-IlI, Patients with a BMI of 35 kg/m2 or less Exclusion Criteria: Patients with lung disease BMI >35kg/m2 Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease) patient refusal

Sites / Locations

  • Gangnam Severacne Hospital Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conventional PEEP

optimized PEEP

Arm Description

Apply of PEEP 5

Apply of optimized PEEP derived using EIT (airtom®)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
ROI (region of interests)
region of interest using EIT
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.
total amount of fluid administered during surgery
total dose of vasopressor administered during surgery
length of hospitalization after surgery

Full Information

First Posted
December 9, 2022
Last Updated
August 10, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05669443
Brief Title
Effect of Optimized PEEP on Mechanical Ventilation During Robot Assisted Laparoscopic Prostatectomy
Official Title
Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional PEEP
Arm Type
Experimental
Arm Description
Apply of PEEP 5
Arm Title
optimized PEEP
Arm Type
Active Comparator
Arm Description
Apply of optimized PEEP derived using EIT (airtom®)
Intervention Type
Device
Intervention Name(s)
conventional PEEP
Intervention Description
Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.
Intervention Type
Device
Intervention Name(s)
optimized PEEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
PaO2/FiO2
Description
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.
Time Frame
end of surgery (before extubation)
Secondary Outcome Measure Information:
Title
PaO2/FiO2
Description
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.
Time Frame
15 minutes after intubation, 1 hour after pnemoperitoneum
Title
ROI (region of interests)
Description
region of interest using EIT
Time Frame
15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
Title
inhomogeneity index
Description
inhomogeneity index : this index calculated from tidal EIT images representing the difference in impedance between the end of inspiration and the end of expiration.
Time Frame
15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
Title
total amount of fluid administered during surgery
Time Frame
end or surgery
Title
total dose of vasopressor administered during surgery
Time Frame
end of surgery
Title
length of hospitalization after surgery
Time Frame
1 month after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital, ASA-PS (American Society of Anesthesiology Body Rating) I-IlI, Patients with a BMI of 35 kg/m2 or less Exclusion Criteria: Patients with lung disease BMI >35kg/m2 Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease) patient refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chul-Ho Chang
Phone
82-2-2019-4601
Email
ANEZZANG@yuhs.ac
Facility Information:
Facility Name
Gangnam Severacne Hospital Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwon Lee
Phone
82-2-2019-4601
Email
BELIEF705@yuhs.ac

12. IPD Sharing Statement

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

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