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

NCT05669443 | Recruiting

• 1 other identifier: 3-2022-0361
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PaO2/FiO2

  15 minutes after intubation, 1 hour after pnemoperitoneum

• ROI (region of interests)

  15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)

• inhomogeneity index

  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

Study Arms (2)

conventional PEEP

EXPERIMENTAL

Apply of PEEP 5

Device: conventional PEEP

optimized PEEP

ACTIVE COMPARATOR

Apply of optimized PEEP derived using EIT (airtom®)

Device: optimized PEEP

Interventions

conventional PEEP DEVICE

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

conventional PEEP

optimized PEEP 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.

optimized PEEP

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Chul-Ho Chang

CONTACT

82-2-2019-4601; ANEZZANG@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 30, 2022
• Study Start: April 3, 2023
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

KR (1)