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NCT Number: NCT06307704

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

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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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%.

Primary outcomes

  1. Post-operative lung consolidation

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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