Preoxygenation Before Prehospital Tracheal Intubation Wit... | NCT01232153

Studies
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon

NCT01232153

Sponsor

Hopital of Melun

Status

Withdrawn

Last Update Posted

Sep 2, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Preoxygenation

Interventions

Non invasive ventilation

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

departure without replacement of the principal investigator

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Oct 29, 2010

First Submission Date that Met QC Criteria

Nov 1, 2010

First Posted Date

Nov 2, 2010Estimated

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

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Name	Class
Service d'Aide Médicale Urgente de Seine et Marne	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

Detailed Description

This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIV preoxygenation	Active Comparator		Device: Non invasive ventilation
Classical preoxygenation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non invasive ventilation	Device	Non invasive ventilation	NIV preoxygenation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
length of hypoxemia	SpO2 below 85%	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients needing chest tube intubation

Exclusion Criteria:

Cardiac arrest
Children
Pregnancy
Incompetents

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

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
SAMU 77		Melun		77000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided