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Active, not recruitingNCT06307704Updated Mar 18, 2026

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

An interventional study of Lung Ultrasound - guided Stepwise PEEP and Standard Ventilation Protocol in Prostate Cancer, Urinary Bladder Cancer and Surgery, sponsored by Nazmy Edward Seif. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    US - PEEP group

    Lung Ultrasound - guided Positive End Expiratory Pressure group

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

  • Active comparator
    Standard group

    Standard Ventilation group

    Procedure: Standard Ventilation Protocol

Interventions

  • ProcedureLung 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.

  • ProcedureStandard 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%.

05

What researchers measure

Primary outcomes

  1. Post-operative lung consolidation

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

    Time frame: 24 hours

06

Study locations

1 site
  • Cairo University Hospitals
    Cairo, Egypt
07

Registry details

Key details

Study ID
NCT06307704
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Mar 13, 2024
Start date
Apr 1, 2024
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Ashgan R Ali, MD
study chair · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Mikhael, MD
principal investigator · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Mustafa E Mohamed, MD
study director · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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