ClinicalTrials.gg
CompletedNCT06307704Updated Oct 20, 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. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

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

Updated Oct 20, 2026Now CompletedEnrollment updatedGo to Updates ↓
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

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 88 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Nazmy Edward Seif is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • more than 40.
  • Moderate to severe obstructive pulmonary disease ( \< 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 ( 3 or 4).
  • Patients who received invasive mechanical ventilation within the last 30 days before surgery.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

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

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%.

06

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

07

Study locations

1 site
  • Cairo University Hospitals
    Cairo, Egypt
08

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

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 1, 2026
Completion
Apr 1, 2026
Last update
Oct 20, 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 ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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