NCT01994928

Brief Summary

Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

November 20, 2013

Last Update Submit

January 31, 2021

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Mean decrease in the saturation of oxygen (SpO2) during intubation.

    Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 \[%\]) during intubation.

    during intubation

Secondary Outcomes (1)

  • Changes in blood gases after intubation.

    30 minutes after intubation

Other Outcomes (1)

  • Changes in hemodynamics.

    during intubation and up to 30 minutes after intubation

Study Arms (2)

Nose-mouth mask

ACTIVE COMPARATOR

Performance of intubation after preoxygenation using a nose-mouth mask.

Device: Nose-mouth maskProcedure: Intubation

High flow nasal cannula oxygen

EXPERIMENTAL

Performance of intubation after preoxygenation using high flow nasal cannula oxygen.

Device: High flow nasal cannula oxygenProcedure: Intubation

Interventions

Nose-mouth maskDEVICE

Preoxygenation using a nose-mouth mask.

Nose-mouth mask
High flow nasal cannula oxygenDEVICE

Preoxygenation using high flow nasal cannula oxygen.

High flow nasal cannula oxygen
IntubationPROCEDURE

Intubation

High flow nasal cannula oxygenNose-mouth mask

Eligibility Criteria

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

You may qualify if:

  • patients treated in an intensive care unit
  • indication for intubation
  • presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure
  • informed consent

You may not qualify if:

  • blocked nasopharynx
  • contraindications for nose-mouth mask or high flow nasal cannula oxygen
  • expected difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Simon M, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.

    PMID: 27274092RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Intubation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Stefan Kluge

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 3, 2021

Record last verified: 2021-01

Locations

DE(1)