Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients

Not Applicable

Recruiting

• Conditions: Urinary Bladder Cancer; Lung Ultrasound; Surgery; Positive End Expiratory Pressure; Prostate Cancer
• Interventions: Procedure: Lung Ultrasound - guided Stepwise PEEP; Procedure: Standard Ventilation Protocol

• Registration Number: NCT06307704
• Lead Sponsor: Nazmy Edward Seif

Brief Summary

There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).

Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.

Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.

The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-13
• Study Start: 2024-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• ASA I, II & III.
• Normal respiratory functions or mild lung disease.

Exclusion Criteria

• BMI more than 40.
• Moderate to severe obstructive pulmonary disease (FEV1 < 80% of predicted).
• Moderate to severe restrictive pulmonary disease (TLC < 70% of predicted).
• Severe pulmonary hypertension (mean PAP>55).
• Previous lung surgery.
• Decompensated cardiac disease (NYHA 3 or 4).
• Patients who received invasive mechanical ventilation within the last 30 days before surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US - PEEP group	Lung Ultrasound - guided Stepwise PEEP	Lung Ultrasound - guided Positive End Expiratory Pressure group
US - PEEP group	Standard Ventilation Protocol	Lung Ultrasound - guided Positive End Expiratory Pressure group
Standard group	Standard Ventilation Protocol	Standard Ventilation group

Primary Outcome Measures

Name	Time	Method
Post-operative lung consolidation	24 hours	Presence (or not) of post-operative lung consolidation detected by lung ultrasound.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt