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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06307704
Enrollment
88
Registered
2024-03-13
Start date
2024-04-01
Completion date
2026-04-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Ultrasound, Positive End Expiratory Pressure, Prostate Cancer, Surgery, Urinary Bladder Cancer

Keywords

Radical Cystectomy, Radical Prostatectomy, Robotic, Anesthesia, Lung-Ultrasound, Positive End Expiratory Pressure

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.

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%.

Sponsors

Nazmy Edward Seif
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative lung consolidation24 hoursPresence (or not) of post-operative lung consolidation detected by lung ultrasound.

Countries

Egypt

Contacts

STUDY_CHAIRAshgan R Ali, MD

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

PRINCIPAL_INVESTIGATORNazmy S Mikhael, MD

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

STUDY_DIRECTORMustafa E Mohamed, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026