Prostate CancerNCT06307704
Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients
A study testing Lung Ultrasound - guided Stepwise PEEP and Standard Ventilation Protocol in people with Prostate Cancer and Urinary Bladder Cancer, run by Nazmy Edward Seif at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prostate Cancer, Urinary Bladder Cancer, Surgery
- What is being tested?
- Lung Ultrasound - guided Stepwise PEEP and Standard Ventilation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I, II \& III.
- Normal respiratory functions or mild lung disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Lung Ultrasound - guided Stepwise PEEP, Standard Ventilation Protocol
- Keywords
- Radical Cystectomy, Radical Prostatectomy, Robotic, Anesthesia, Lung-Ultrasound, Positive End Expiratory Pressure
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound - guided Stepwise PEEPProcedure or surgery
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 ProtocolProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| US - PEEP group | Experimental | Lung Ultrasound - guided Positive End Expiratory Pressure group Receives: Procedure: Lung Ultrasound - guided Stepwise PEEP; Procedure: Standard Ventilation Protocol |
| Standard group | Active comparator | Standard Ventilation group Receives: Procedure: Standard Ventilation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative lung consolidation
Presence (or not) of post-operative lung consolidation detected by lung ultrasound.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Ashgan R Ali, MD, Study chair, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityNazmy S Mikhael, MD, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityMustafa E Mohamed, MD, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307704
- Sponsor's protocol ID
- LUSPEEPORRPC
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Bedside Lung-ultrasound Use to Optimize Positive End-expiratory Pressure for Elective Robotic-assisted Radical Prostatectomy or Cystectomy Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06307704
- Acronym / sponsor ID
- LUSPEEPORRPC
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US - PEEP group | Experimental | Procedure: Lung Ultrasound - guided Stepwise PEEP, Procedure: Standard Ventilation ProtocolLung Ultrasound - guided Positive End Expiratory Pressure group |
| Standard group | Active comparator | Procedure: Standard Ventilation ProtocolStandard Ventilation group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I, II \& III.
- Normal respiratory functions or mild lung disease.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Ultrasound - guided Stepwise PEEPAfter 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 or surgery | US - PEEP group |
| Standard Ventilation ProtocolVolume-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%. | Procedure or surgery | Standard group, US - PEEP group |
Primary outcome
Post-operative lung consolidation
Time frame: 24 hours
Presence (or not) of post-operative lung consolidation detected by lung ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Ultrasound - guided Stepwise PEEP and Standard Ventilation Protocol in people with Prostate Cancer and Urinary Bladder Cancer, run by Nazmy Edward Seif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative lung consolidation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.