Clinical trial NCT06307704: Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Urinary Bladder Cancer
Surgery
Positive End Expiratory Pressure
Lung Ultrasound
Keywords: Radical Cystectomy
Radical Prostatectomy
Robotic
Anesthesia
Lung-Ultrasound
Positive End Expiratory Pressure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Post-operative lung consolidation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Ashgan R Ali, MD
role: STUDY_CHAIR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Nazmy S Mikhael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Mustafa E Mohamed, MD
role: STUDY_DIRECTOR
References: