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

NCT05261295 | Unknown

• 1 other identifier: E1-21-2260
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Positive End Expiratory Pressure; Lung Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Classical LMA

Patients who received general anesthesia with classical LMA

Diagnostic Test: PEEP; Diagnostic Test: ZEEP

i-Gel

Patients who received general anesthesia with i-Gel

Diagnostic Test: PEEP; Diagnostic Test: ZEEP

Interventions

PEEP DIAGNOSTIC_TEST

PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.

Classical LMA; i-Gel

ZEEP DIAGNOSTIC_TEST

PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.

Classical LMA; i-Gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Officials

• canan ün, MD

  ankara ch bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Demirörs, MD

CONTACT

+905548997181; drahmetdemirors@gmail.com

canan ün, MD

CONTACT

905306450054; cananun@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 2, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02