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

NCT ID: NCT06307704

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

US - PEEP group

Lung Ultrasound - guided Positive End Expiratory Pressure group

Group Type: EXPERIMENTAL

Lung Ultrasound - guided Stepwise PEEP

Intervention Type: 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.

Standard Ventilation Protocol

Intervention Type: 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

Standard Ventilation group

Group Type: ACTIVE_COMPARATOR

Standard Ventilation Protocol

Intervention Type: 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%.

Interventions

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.

Intervention Type: 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%.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nazmy Edward Seif

OTHER

Sponsor Role: lead

Responsible Party

Nazmy Edward Seif

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ashgan R Ali, MD

Role: STUDY_CHAIR

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

Nazmy S Mikhael, MD

Role: PRINCIPAL_INVESTIGATOR

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

Mustafa E Mohamed, MD

Role: STUDY_DIRECTOR

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

Locations

Cairo University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

LUSPEEPORRPC

Identifier Type: -

Identifier Source: org_study_id