HFNC for Induction During Bariatric Surgery Patients.

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Completed
CT.gov ID
NCT03155711
Collaborator
(none)
64
1
2
7.9
8.2

Study Details

Study Description

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
  • Procedure: HFNC group
  • Procedure: Standard group
N/A

Study Design

Study Type:
Interventional
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 :
Sep 30, 2017
Actual Study Completion Date :
Dec 30, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Oxygenation [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 [First 24 postoperative hours]

    PaO2/FIO2

  2. Atelectasis [First 24 postoperative hours]

    Atelectasis evaluated with X-ray

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital clínico universitario Valencia Spain 46010

Sponsors and Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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
Last Update Posted:
Feb 26, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2018