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Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.

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ClinicalTrials.gov Identifier: NCT01994928
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date February 3, 2021
Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2021)
Mean decrease in the saturation of oxygen (SpO2) during intubation. [ Time Frame: during intubation ]
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Mean decrease in the saturation of oxygen (SpO2) during intubation. [ Time Frame: during intubation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2021)
Changes in blood gases after intubation. [ Time Frame: 30 minutes after intubation ]
Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Changes in blood gases after intubation. [ Time Frame: 30 minutes after intubation ]
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2021)
Changes in hemodynamics. [ Time Frame: during intubation and up to 30 minutes after intubation ]
Changes in mean arterial pressure [mmHg] measured via arterial line.
Original Other Pre-specified Outcome Measures
 (submitted: November 20, 2013)
Changes in hemodynamics. [ Time Frame: during intubation and up to 30 minutes after intubation ]
 
Descriptive Information
Brief Title  ICMJE Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.
Official Title  ICMJE Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Failure
Intervention  ICMJE
  • Device: Nose-mouth mask
    Preoxygenation using a nose-mouth mask.
  • Device: High flow nasal cannula oxygen
    Preoxygenation using high flow nasal cannula oxygen.
  • Procedure: Intubation
    Intubation
Study Arms  ICMJE
  • Active Comparator: Nose-mouth mask
    Performance of intubation after preoxygenation using a nose-mouth mask.
    Interventions:
    • Device: Nose-mouth mask
    • Procedure: Intubation
  • Experimental: High flow nasal cannula oxygen
    Performance of intubation after preoxygenation using high flow nasal cannula oxygen.
    Interventions:
    • Device: High flow nasal cannula oxygen
    • Procedure: Intubation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
50
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • blocked nasopharynx
  • contraindications for nose-mouth mask or high flow nasal cannula oxygen
  • expected difficult airway
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994928
Other Study ID Numbers  ICMJE PV-4429
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP