NCT01947257

Brief Summary

The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients. The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

July 31, 2013

Last Update Submit

August 29, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • measure of the pulmonary artery pressure

    12 months

Study Arms (1)

ventilated patients

OTHER
Other: the measure TRVMAXOther: the measure of the pulmonary arteryOther: the direct measure of the pulmonary pressures

Interventions

by transthoracic echocardiography

ventilated patients

by transesophageal ultrasound

ventilated patients

by right catheterization

ventilated patients

Eligibility Criteria

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

You may qualify if:

  • Patients aged over 18 years
  • Admitted to intensive care
  • Mechanically ventilated and sedated
  • Carrying a right catheterization
  • Making a ETO indicated by the medical team or doctor in charge of the patient

You may not qualify if:

  • Patients under 18 years
  • expectant mother
  • Patients without health insurance
  • Refusal to close

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

September 20, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations