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

NCT ID: NCT05669443

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-11-10

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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conventional PEEP

Apply of PEEP 5

Group Type EXPERIMENTAL

conventional PEEP

Intervention Type DEVICE

Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.

optimized PEEP

Apply of optimized PEEP derived using EIT (airtom®)

Group Type ACTIVE_COMPARATOR

optimized PEEP

Intervention Type DEVICE

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.

Interventions

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conventional PEEP

Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul Ho Chang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chul-Ho Chang

Role: CONTACT

82-2-2019-4601

Facility Contacts

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Jiwon Lee

Role: primary

82-2-2019-4601

Other Identifiers

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3-2022-0361

Identifier Type: -

Identifier Source: org_study_id

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