NCT03746236

Brief Summary

Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

September 11, 2019

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

November 14, 2018

Last Update Submit

September 10, 2019

Conditions

Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (2)

  • Incidence of postoperative acute complications

    Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization

    24 hours

  • Dosage of inflammatory mediators

    Dosage of metalloproteinase and interleukin 8 in bronchoaspiration

    24 hours

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent laparoscopic or robotic assisted radical prostatectomy

You may qualify if:

  • ASA (american society of anesthesiologists) score ≤ III
  • Patients underwent laparoscopic prostatectomy

You may not qualify if:

  • BMI (body mass index) ≥ 30
  • Impossibility to insert nasogastric tube
  • Anatomic rib cage alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regina Elena National Cancer Institute

Rome, Rm, 00153, Italy

RECRUITING

Regina Elena National Cancer Institute

Rome, 00154, Italy

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ester Forastiere, chief

CONTACT

ester.forastiere@ifo.gov.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anaestesiology and Critical Care

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 19, 2018

Study Start

November 14, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

September 11, 2019

Record last verified: 2018-11

Locations

IT(2)