NCT01782430

Brief Summary

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

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
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

January 31, 2013

Last Update Submit

June 24, 2016

Conditions

Adult PatientsRequiring IntubationHypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)Patient Covered by French Health Care System

Keywords

PreoxygenationIntubation

Outcome Measures

Primary Outcomes (1)

  • least pulse oxymetry value

    at day 1

Secondary Outcomes (4)

  • pulse oxymetry value (at the end of preoxygenation)

    at 5 minutes and at 30 minutes after intubation

  • Partial pressure of arterial oxygen (PaO2)

    at day 1

  • Regurgitation rate

    at day 1

  • oxyhemoglobin desaturation below 80 %

    at day 1

Study Arms (3)

Standard oxygenation

EXPERIMENTAL

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Procedure: - standard oxygenation

High flow nasal oxygen therapy

EXPERIMENTAL

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Procedure: - standard oxygenation

invasive ventilation (VNI)

OTHER

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Procedure: - standard oxygenation

Interventions

- standard oxygenationPROCEDURE
High flow nasal oxygen therapyStandard oxygenationinvasive ventilation (VNI)

Eligibility Criteria

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

You may qualify if:

  • adults patients
  • requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
  • patient covered by french health care system

You may not qualify if:

  • patient refusal
  • intubation for other causes (excluding hypoxemia)
  • impossibility to measure pulse oxymetry value
  • contraindication for NIV : vomiting
  • NIV intolerance
  • cardiac arrest during intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 1, 2013

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)