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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05669443
Enrollment
42
Registered
2022-12-30
Start date
2023-04-03
Completion date
2024-11-10
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

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

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.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO2end 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

MeasureTime frameDescription
ROI (region of interests)15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)region of interest using EIT
inhomogeneity index15 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.
PaO2/FiO215 minutes after intubation, 1 hour after pnemoperitoneumpartial 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 surgeryend of surgery
length of hospitalization after surgery1 month after surgery
total amount of fluid administered during surgeryend or surgery

Countries

South Korea

Contacts

Primary ContactChul-Ho Chang
ANEZZANG@yuhs.ac82-2-2019-4601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026