NCT02551341

Brief Summary

Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assisted robotic radical prostatectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

September 13, 2015

Last Update Submit

November 15, 2018

Conditions

Prostate Cancer

Keywords

prostatectomyrobotic

Outcome Measures

Primary Outcomes (1)

  • PaO2 2 hours postoperatively after 10 minutes of spontaneous respiration of atmospheric air

    10 minutes

Secondary Outcomes (1)

  • Difference in cytokines released from lung tissue measured by IL-6.

    2 days

Study Arms (2)

control

NO INTERVENTION

normal ventilation

intervention

EXPERIMENTAL

higher PEEP ventilation

Procedure: higher PEEP ventilation

Interventions

higher PEEP ventilationPROCEDURE
intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years
  • Men
  • Indication for robot-assisted radical prostatectomy acc. the department's instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitalsenheden Vest

Holstebro, 8200, Denmark

Location

Related Publications (1)

  • Hoyer S, Mose FH, Ekelof P, Jensen JB, Bech JN. Hemodynamic, renal and hormonal effects of lung protective ventilation during robot-assisted radical prostatectomy, analysis of secondary outcomes from a randomized controlled trial. BMC Anesthesiol. 2021 Aug 5;21(1):200. doi: 10.1186/s12871-021-01401-x.

    PMID: 34348666DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

DK(1)