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

NCT06307704 | Active Not Recruiting

• 1 other identifier: LUSPEEPORRPC
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urinary Bladder Cancer; Surgery; Positive End Expiratory Pressure; Lung Ultrasound

Keywords

Radical Cystectomy; Radical Prostatectomy; Robotic; Anesthesia; Lung-Ultrasound; Positive End Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• Post-operative lung consolidation

  Presence (or not) of post-operative lung consolidation detected by lung ultrasound.

  24 hours

Study Arms (2)

US - PEEP group

EXPERIMENTAL

Lung Ultrasound - guided Positive End Expiratory Pressure group

Procedure: Lung Ultrasound - guided Stepwise PEEP; Procedure: Standard Ventilation Protocol

Standard group

ACTIVE COMPARATOR

Standard Ventilation group

Procedure: Standard Ventilation Protocol

Interventions

Lung Ultrasound - guided Stepwise PEEP PROCEDURE

After endo-tracheal intubation; A PEEP of 4 cmH2O will be initially used till 5 min after pneumoperitoneum. Then The PEEP will be adjusted in a stepwise approach after performing bedside lung ultrasound. The PEEP will be increased by 2 cmH2O until no lung collapse is detected. Lung ultrasound will be repeated 5 min after every change in the PEEP with a maximal PEEP of 12 cmH2O.

US - PEEP group

Standard Ventilation Protocol PROCEDURE

Volume-controlled ventilation (VCV) mode; with a tidal volume of 6 mL/kg of ideal weight, inspiratory : expiratory ratio 1: 2, PEEP 4 cmH2O, respiratory rate adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mm Hg, and inspired oxygen fraction of 50%.

Standard group; US - PEEP group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Officials

• Ashgan R Ali, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Nazmy S Mikhael, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

• Mustafa E Mohamed, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

EG (1)