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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

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).

Condition or disease Intervention/treatment Phase
Lung Collapse Procedure: HFNC group Procedure: Standard group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: HFNC group
Positive pressure plus supplemental oxygen through a high flow nasal oxygen device

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.
Procedure: Standard group
Supplemental oxygen through venturi mask




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Oxygenation [ Time Frame: First 24 postoperative hours ]
    PaO2/FIO2

  2. Atelectasis [ Time Frame: First 24 postoperative hours ]
    Atelectasis evaluated with X-ray



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155711


Locations
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Spain
Hospital clínico universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Publications:
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Responsible Party: Carlos Ferrando, Principal Investigador, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT03155711    
Other Study ID Numbers: HFNC-Obese
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases