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

Lung Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05261295
• Other study ID #: E1-21-2260
• Status: Not yet recruiting
• Start date: March 2022
• Est. completion date: July 2022

Study information

• Verified date: February 2022
• Source: Ankara City Hospital Bilkent
• Contact: Ahmet Demirörs, MD
• Phone: +905548997181
• Email: drahmetdemirors[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Ultrasound
• Positive End Expiratory Pressure

Intervention

Diagnostic Test:
• PEEP
PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.
• ZEEP
PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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