NCT01868347

Brief Summary

Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

May 23, 2013

Last Update Submit

June 5, 2013

Conditions

Obese Patients With Prostate Cancer Disease

Keywords

obese patientsspecific elastanceTrendelenburg PositionPneumoperitoneumrobotic surgeryProstatectomy

Outcome Measures

Primary Outcomes (1)

  • evaluation of arterial oxygenation

    at 6 hours (average duration of surgery procedure)

Secondary Outcomes (2)

  • evaluation of specific static elastance of the lung

    at 6 hours (average duration of surgery procedure)

  • evaluation of difference between arterial end-tidal partial pressure of carbon dioxide

    at 6 hours (average duration of surgery procedure)

Other Outcomes (1)

  • variation of gas exchange in post operative period

    at 1 week (average duration)

Study Arms (2)

control

ACTIVE COMPARATOR

PEEP after pneumoperitoneum and trendelenburg

Other: control

Treatment

EXPERIMENTAL

preemptive PEEP before pneumoperitoneum and trendelenburg

Other: treatment

Interventions

treatmentOTHER

preemptive PEEP before pneumoperitoneum and trendelenburg

Treatment
controlOTHER

PEEP after pneumoperitoneum and trendelenburg

control

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>= 30
  • Robotic-assisted laparoscopic prostatectomy

You may not qualify if:

  • Chronic cardiac or pulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O.U San Luigi Gonzaga Hospital, Univesity of Turin

Turin, Italy, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Pierpaolo Terragni, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Augusto Tempia, MD

    University of Turin, Italy

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 4, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 6, 2013

Record last verified: 2013-05

Locations

IT(1)