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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