Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position

Comparison of PEEP Applying in Terms of Perioperative Oxygenation and Postoperative Pulmonary Complications in the Use of Classical LMA and I-gel in Urological Surgery Procedures in Lithotomy Position

The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.

Study Overview

• Status: Not yet recruiting
• Conditions: Positive End Expiratory Pressure; Lung Ultrasound
• Intervention / Treatment: Diagnostic test: PEEP; Diagnostic test: ZEEP

• Study Type: Observational
• Enrollment (Anticipated): 128

Contacts and Locations

• Study Contact: Name: Ahmet Demirörs, MD; Phone Number: +905548997181; Email: drahmetdemirors@gmail.com
• Study Contact Backup: Name: canan ün, MD; Phone Number: 905306450054; Email: cananun@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy

Description

Inclusion Criteria:

• ASA I-III
• Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy

Exclusion Criteria:

• Heart failure (ejection fraction < 40%),
• unstable hemodynamic conditions
• Having neck or upper respiratory tract pathology,
• have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),
• obesity (body mass index≥30 kg m-2)
• Patients with poor tooth structure will also be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Classical LMA; Patients who received general anesthesia with classical LMA	Diagnostic test: PEEP; PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.; Diagnostic test: ZEEP; PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.
i-Gel; Patients who received general anesthesia with i-Gel	Diagnostic test: PEEP; PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.; Diagnostic test: ZEEP; PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LUS score preop	Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.	Baseline
LUS score postoperative	Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.	postoperative 1.hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: canan ün, MD, Ankara CH bilkent

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (ACTUAL): March 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: E1-21-2260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No