NCT01232153

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
6.3 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

October 29, 2010

Last Update Submit

August 31, 2020

Conditions

Preoxygenation

Keywords

chest tubepreoxygenationNIVout-of-hospitalpatients needing tracheal chest tube managed by Medical Mobile Emergency rescue services

Outcome Measures

Primary Outcomes (1)

  • length of hypoxemia

    SpO2 below 85%

    5 minutes

Study Arms (2)

NIV preoxygenation

ACTIVE COMPARATOR
Device: Non invasive ventilation

Classical preoxygenation

NO INTERVENTION

Interventions

Non invasive ventilationDEVICE

Non invasive ventilation

NIV preoxygenation

Eligibility Criteria

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

You may qualify if:

  • Patients needing chest tube intubation

You may not qualify if:

  • Cardiac arrest
  • Children
  • Pregnancy
  • Incompetents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMU 77

Melun, 77000, France

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 2, 2010

Study Start

March 1, 2017

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

FR(1)