To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT06307704

Condition: Prostate Cancer
Urinary Bladder Cancer
Surgery
Positive End Expiratory Pressure
Lung Ultrasound

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: Keywords:
Radical Cystectomy
Radical Prostatectomy
Robotic
Anesthesia
Lung-Ultrasound
Positive End Expiratory Pressure

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Lung Ultrasound - guided Stepwise PEEP
Description: 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.
Arm group label: US - PEEP group

Intervention type: Procedure
Intervention name: Standard Ventilation Protocol
Description: 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%.
Arm group label: Standard group
Arm group label: US - PEEP group

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cairo University Hospitals

Address:
City: Cairo
Country: Egypt

Status: Recruiting

Contact:
Last name: Mustafa E Mohamed, MD

Phone: 01140806330

Phone ext: +2
Email: mustafaemam931@gmail.com

Contact backup:
Last name: Nazmy S Mikhael, MD

Phone: 01227400808

Phone ext: +2
Email: nazmy.edwar.seif@gmail.com

Start date: April 1, 2024

Completion date: October 2024

Lead sponsor:
Agency: Nazmy Edward Seif
Agency class: Other

Source: Cairo University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06307704

Login to your account

Did you forget your password?