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HFNC for Induction During Bariatric Surgery Patients.

Primary Purpose

Lung Collapse

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HFNC group
Standard group
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Collapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital clínico universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFNC

Standard

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Oxygenation
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

Oxygenation
PaO2/FIO2
Atelectasis
Atelectasis evaluated with X-ray

Full Information

First Posted
May 15, 2017
Last Updated
February 23, 2018
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03155711
Brief Title
HFNC for Induction During Bariatric Surgery Patients.
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Collapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC
Arm Type
Experimental
Arm Description
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
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
HFNC group
Intervention Description
Positive pressure plus supplemental oxygen through a high flow nasal oxygen device
Intervention Type
Procedure
Intervention Name(s)
Standard group
Intervention Description
Supplemental oxygen through venturi mask
Primary Outcome Measure Information:
Title
Oxygenation
Description
The oxygenation (the ratio of partial pressure of arterial oxygen with inspiratory oxygen fraction, PaO2/FIO2) informs of the percentadge of shunt.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Oxygenation
Description
PaO2/FIO2
Time Frame
First 24 postoperative hours
Title
Atelectasis
Description
Atelectasis evaluated with X-ray
Time Frame
First 24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital clínico universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12456460
Citation
Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
Results Reference
background
PubMed Identifier
15105237
Citation
Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
Results Reference
background
PubMed Identifier
25081420
Citation
Ireland CJ, Chapman TM, Mathew SF, Herbison GP, Zacharias M. Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery. Cochrane Database Syst Rev. 2014 Aug 1;2014(8):CD008930. doi: 10.1002/14651858.CD008930.pub2.
Results Reference
background

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HFNC for Induction During Bariatric Surgery Patients.

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