Lung Protective Ventilation During Robotic Assisted Prostatectomy

November 15, 2018 updated by: Jørgen Bjerggaard Jensen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Protocol Summary

Purpose:

The project will investigate whether a suspected lung protective ventilator therapy in connection with surgery for cancer of the prostate (prostate) have a relevant beneficial effects on lung function, renal function and circulation associated with keyhole surgery performed with surgical robot.

Trial method:

The trial is a randomized study (randomized controlled trials), which are drawn between normal and a suspected lung protective ventilator treatment in connection with the surgical removal of the prostate due to Cancers. Before the operation, collected urine and blood samples and that a study of lung function and circulation as a starting point. During the operation, and in the following two days collected urine and blood samples. Prepare Furthermore, new studies of lung function and circulation. Blood tests and lung function studied also in outpatient control about 1 week after surgery.

The two groups of patients (for respectively normal respiratory therapy and suspected lung protective) compared subsequent terms. Impact on lung function, renal function and circulation as well as the number and severity of any complications compared to assess whether the suspected lung protective ventilator therapy is safe and provides adequate beneficial effect to introduce as standard in the future.

Tissue sampling used in the form of blood tests or urine tests MHP research biobank in the experiment. This tissue will be used for analyzes in the specific project and the tissue will be destroyed after current guidelines for project completion.

Side effects and risks:

There are at every blood sampling a small risk of infection and bleeding. Using standard sterile technique. Blood volume removed by blood tests is max of 250 ml in total. Removing this amount of blood does not entail health risks in patients. There may be discomfort around the injection site, the needle drop is wrong in the arm, but using standard sterile technique and dropped down by experienced personnel. Blood samples for the experiment performed during routine blood sampling equipment as specified in the department's instructions.

For lung studies will in some cases could be detected a certain constriction of the small branches of the airways (bronchi). To determine whether this is a condition may require treatment given ally a spray to suck, which aims to expand the branches in order to improve lung function. This medication can cause slight transient dizziness and palpitations.

Disadvantages:

The additional lung examinations in the study will attempt established in connection with the patient's usual attendance and stay at the hospital to avoid extra visits. There must be calculated some extra time spent for outpatient visits in connection with participation in the trial. There is no economic disadvantages associated with the trial for the patient.

Economic conditions:

There is no economic disadvantages associated with the trial for the patient. Funding for the project will be done through a joint financing by the Urology Department D, Department of Anesthesiology and University Clinic for Kidney disease and high blood pressure, Hospital West and Aarhus University. Research funds will be sought from public and private funds.

Publication of trial results:

The results, both positive and negative findings, will be made published in internationally recognized scientific journal anonymously with no personally identifiable data.

Research Ethics statement:

The project reported to the Ethical Science Council at the Central Denmark Region. Database for the project must be approved by the Data Protection Agency by Region of Central. The project is started only after the approval of these two bodies. The project will comply with applicable GCP rules.

Recruitment of participants:

First contacting the patient about the project via the operator, Urology Department, at the information interview on operation. If the patient wants to get further information about the project handed out written information and project manager contacted.

The written information consists of: Participant Information, consent form, "Information for subjects" and "Your Rights as a test subject in a biomedical research." The patient is informed both in writing and orally on the right and the opportunity to bring legal counsel to informed consent.

The project manager or his representative hold subsequent information interview about 7 days before surgery. This will last approximately 30 minutes. Information being conducted in consultation room at the clinic, where there is no other activity in the allocated room during the interview.

The anesthesia controller or his deputy hold right now usual anesthesia monitoring and ensuring written consent.

At the oral information, patients will be informed that there is a request to participate in a biomedical research. Patients are informed acc. the guidelines in "Guidelines for review, etc. of a biomedical research for the ethics committee system "from the Central Scientific Ethical Committee. Information is provided for the experiment, as listed in Annex 1 "Information for volunteers." The subjects, who wish to participate are advised that, if they wish, can get consideration before submitting their written consent to participate in research is voluntary, and that they will always be able to draw a committed participation back .

The subjects were informed that they will receive information on the results achieved by research reporting on the project if they are interested in this.

Written informed consent given to the project manager or the anesthetic consultant or his deputy in the project in connection with the information interview, journal recording and anesthesia monitoring. The subjects signed concent- and proxy statement, which is kept by the Data Protection Agency guidelines. A copy provided to the subject.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 8200
        • Hospitalsenheden Vest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
normal ventilation
Experimental: intervention
higher PEEP ventilation
Procedure: higher PEEP ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PaO2 2 hours postoperatively after 10 minutes of spontaneous respiration of atmospheric air
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jørgen Bjerggaard Jensen

Collaborators

Hospitalsenheden Vest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEEP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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