HFNC for Induction During Bariatric Surgery Patients.

NCT ID: NCT03155711

Last Updated: 2018-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2017-12-30

Brief Summary

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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

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Conditions

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Lung Collapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HFNC group

Intervention Type PROCEDURE

Positive pressure plus supplemental oxygen through a high flow nasal oxygen device

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.

Group Type ACTIVE_COMPARATOR

Standard group

Intervention Type PROCEDURE

Supplemental oxygen through venturi mask

Interventions

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HFNC group

Positive pressure plus supplemental oxygen through a high flow nasal oxygen device

Intervention Type PROCEDURE

Standard group

Supplemental oxygen through venturi mask

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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Carlos Ferrando

Principal Investigador

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital clínico universitario

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 12456460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15105237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25081420 (View on PubMed)

Other Identifiers

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HFNC-Obese

Identifier Type: -

Identifier Source: org_study_id

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