Lung Protective Ventilation During Robotic Assisted Prostatectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02551341
• Date of registration: 13/09/2015
• Prospective Registration: No
• Primary sponsor: Jørgen Bjerggaard Jensen
• Public title: Lung Protective Ventilation During Robotic Assisted Prostatectomy
• Scientific title: Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Hormones, Biomarkers of Nephrotoxicity and Haemodynamics in Patients Undergoing Robot-assisted Radical Prostatectomy
• Date of first enrolment: September 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02551341
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age> 18 years

- Men

- Indication for robot-assisted radical prostatectomy acc. the department's instructions

Exclusion Criteria:

- Lack of desire to participate

- EGFR <15 ml / min

- BMI> 35 kg / m2

- Former lung surgery

- Known requiring treatment lung disease

- Known heart disease svt NYHA Class III or higher

- Recent AMI within 12 months

- Known neuromuscular disease



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Procedure: higher PEEP ventilation

Primary Outcome(s)

PaO2 2 hours postoperatively after 10 minutes of spontaneous respiration of atmospheric air [Time Frame: 10 minutes]

Secondary Outcome(s)

Difference in cytokines released from lung tissue measured by IL-6. [Time Frame: 2 days]

Secondary ID(s)

PEEP-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospitalsenheden Vest