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

Intraoperative Bedside Lung-ultrasound Use to Optimize Positive End-expiratory Pressure for Elective Robotic-assisted Radical Prostatectomy or Cystectomy Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Surgery; Urinary Bladder Cancer; Positive End Expiratory Pressure; Lung Ultrasound
• Intervention / Treatment: Procedure: Lung Ultrasound - guided Stepwise PEEP; Procedure: Standard Ventilation Protocol

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa E Mohamed, MD; Phone Number: +2 01140806330; Email: mustafaemam931@gmail.com
• Study Contact Backup: Name: Nazmy S Mikhael, MD; Phone Number: +2 01227400808; Email: nazmy.edwar.seif@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals
    • Contact: Mustafa E Mohamed, MD; Phone Number: +2 01140806330; Email: mustafaemam931@gmail.com
    • Contact: Nazmy S Mikhael, MD; Phone Number: +2 01227400808; Email: nazmy.edwar.seif@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: US - PEEP group; Lung Ultrasound - guided Positive End Expiratory Pressure group	Procedure: Lung Ultrasound - guided Stepwise PEEP; 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.; Procedure: Standard Ventilation Protocol; 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%.
Active Comparator: Standard group; Standard Ventilation group	Procedure: Standard Ventilation Protocol; 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative lung consolidation	Presence (or not) of post-operative lung consolidation detected by lung ultrasound.	24 hours

Collaborators and Investigators

• Sponsor: Nazmy Edward Seif
• Investigators: Study Chair: Ashgan R Ali, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University; Principal Investigator: Nazmy S Mikhael, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University; Study Director: Mustafa E Mohamed, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Radical Cystectomy; Robotic; Anesthesia; Radical Prostatectomy; Positive End Expiratory Pressure; Lung-Ultrasound
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: LUSPEEPORRPC

Drug and device information, study documents

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