NCT02816190

Brief Summary

Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

June 24, 2016

Last Update Submit

March 29, 2018

Conditions

Prone PositionMechanical VentilationVolumetric Capnography

Outcome Measures

Primary Outcomes (1)

  • P3Slp

    Evolution of phase 3 slope of volumetric capnography in survivors vs non-survivors

    24 hours

Interventions

prone positionPROCEDURE

Eligibility Criteria

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

All prone positionned patients

You may qualify if:

  • all prone positioned patients

You may not qualify if:

  • age below 18 y, dependant patients, participation reject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melun Hospital ICU

Melun, 77000, France

Location

Related Publications (1)

  • Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.

    PMID: 32449068DERIVED

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • sebastien jochmans, MD

    Clinical Research Unit, Melun Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU MD, Clinical Research Unit Director

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

April 1, 2016

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

FR(1)