PROne POsition and Volumetric CAPnography | NCT02816190

Studies
PROne POsition and Volumetric CAPnography

NCT02816190

Sponsor

Hopital of Melun

Status

Completed

Last Update Posted

Mar 30, 2018Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Prone Position
Mechanical Ventilation
Volumetric Capnography

Interventions

prone position

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Mar 29, 2018Actual

Completion Date

Mar 29, 2018Actual

First Submitted Date

Jun 24, 2016

First Submission Date that Met QC Criteria

Jun 24, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2018

Last Update Posted Date

Mar 30, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sebastien Jochmans, MD, ICU MD, Clinical Research Unit Director, Hopital of MelunPrincipal Investigator

Lead Sponsor

Hopital of MelunOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Name	Type	Description	Arm Group Labels	Other Names
prone position	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
P3Slp	Evolution of phase 3 slope of volumetric capnography in survivors vs non-survivors	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all prone positioned patients

Exclusion Criteria:

age below 18 y, dependant patients, participation reject

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All prone positionned patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sebastien jochmans, MD	Clinical Research Unit, Melun Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melun Hospital ICU		Melun		77000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32449068	Derived	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.

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena