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

NCT06307704 — Not applicable, Completed, 88 participants, Nazmy Edward Seif

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

Registry	NCT06307704
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	88 (Actual)
Sponsor	Nazmy Edward Seif (Other)
Conditions	Prostate Cancer, Urinary Bladder Cancer, Surgery, Positive End Expiratory Pressure, Lung Ultrasound
Interventions	Lung Ultrasound - guided Stepwise PEEP, Standard Ventilation Protocol (Procedure)
Dates	start 2024-04-01, primary completion 2026-04-01, completion 2026-04-01, first posted 2024-03-13, last updated 2026-10-20
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
US - PEEP group	Experimental	Procedure: Lung Ultrasound - guided Stepwise PEEP; Procedure: Standard Ventilation Protocol	Lung Ultrasound - guided Positive End Expiratory Pressure group
Standard group	Active comparator	Procedure: Standard Ventilation Protocol	Standard Ventilation group

Lung Ultrasound - guided Stepwise PEEP (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 (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%.

+Outcome measures

Primary outcomes

Post-operative lung consolidation [24 hours]: Presence (or not) of post-operative lung consolidation detected by lung ultrasound.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

Facility	City	Country	Status
Cairo University Hospitals	Cairo	Egypt

+Investigators

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