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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307704
• Other study ID #: LUSPEEPORRPC
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Mustafa E Mohamed, MD
• Phone: 01140806330
• Email: mustafaemam931[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Ultrasound
• Positive End Expiratory Pressure
• Prostate Cancer
• Surgery
• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Lung 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.
• Standard 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%.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative lung consolidation	Presence (or not) of post-operative lung consolidation detected by lung ultrasound.	24 hours