HFNC for Induction During Bariatric Surgery Patients.

NCT03155711 | Completed

• 1 other identifier: HFNC-Obese
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Collapse

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  The oxygenation (the ratio of partial pressure of arterial oxygen with inspiratory oxygen fraction, PaO2/FIO2) informs of the percentadge of shunt.

  intraoperative

Secondary Outcomes (2)

• Oxygenation

  First 24 postoperative hours

• Atelectasis

  First 24 postoperative hours

Study Arms (2)

HFNC

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

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

Interventions

HFNC group PROCEDURE

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

HFNC

Standard group PROCEDURE

Supplemental oxygen through venturi mask

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital clínico universitario

Valencia, 46010, Spain

Location

Related Publications (3)

• 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.

  PMID: 12456460 BACKGROUND

• 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.

  PMID: 15105237 BACKGROUND

• 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.

  PMID: 25081420 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: May 5, 2017
• Primary Completion: September 30, 2017
• Study Completion: December 30, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)