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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669443
• Other study ID #: 3-2022-0361
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: November 10, 2024

Study information

• Verified date: April 2024
• Source: Gangnam Severance Hospital
• Contact: Chul-Ho Chang
• Phone: 82-2-2019-4601
• Email: ANEZZANG[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 10, 2024
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• conventional PEEP
Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severacne Hospital Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	ROI (region of interests)	region of interest using EIT	15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
Secondary	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)
Secondary	total amount of fluid administered during surgery		end or surgery
Secondary	total dose of vasopressor administered during surgery		end of surgery
Secondary	length of hospitalization after surgery		1 month after surgery