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HFNC for Induction During Bariatric Surgery Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155711
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE May 5, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
Oxygenation [ Time Frame: intraoperative ]
The oxygenation (the ratio of partial pressure of arterial oxygen with inspiratory oxygen fraction, PaO2/FIO2) informs of the percentadge of shunt.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Oxygenation [ Time Frame: First 24 postoperative hours ]
    PaO2/FIO2
  • Atelectasis [ Time Frame: First 24 postoperative hours ]
    Atelectasis evaluated with X-ray
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HFNC for Induction During Bariatric Surgery Patients.
Official Title  ICMJE Study Protocol for the Use of High Flow Nasal Oxygen During the Anesthesia Induction and Weaning in Patients Scheduled for Bariatric Surgery. A Randomized Pilot Study
Brief Summary This study aims to compared the effects of high flow nasal during the induction and during the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which consists in supplemental oxygen with face mask (Venturi mask).
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: Prevention
Condition  ICMJE Lung Collapse
Intervention  ICMJE
  • Procedure: HFNC group
    Positive pressure plus supplemental oxygen through a high flow nasal oxygen device
  • Procedure: Standard group
    Supplemental oxygen through venturi mask
Study Arms  ICMJE
  • Experimental: HFNC
    HFNC with a 60 liters per minute flow will be given to the patients before anesthesia induction and before extubation at the end of the surgery
    Intervention: Procedure: HFNC group
  • Active Comparator: Standard
    This patients will be managed as usual care. Pre-oxygenation before induction will be performed with supplemental oxygen but without positive pressure. After extubation patients will be oxygenated through a ventury mask.
    Intervention: Procedure: Standard group
Publications *

*   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: November 10, 2017)
64
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
32
Actual Study Completion Date  ICMJE December 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index > 35 Kg/m2
  • Bariatric surgery
  • Informed consent signed

Exclusion Criteria:

  • age <18yr or >80yr
  • pregnancy or breast-feeding status
  • patients with previous known respiratory disease
  • hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device
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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03155711
Other Study ID Numbers  ICMJE HFNC-Obese
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
Study Sponsor  ICMJE Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundación para la Investigación del Hospital Clínico de Valencia
Verification Date February 2018

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