HFNC for Induction During Bariatric Surgery Patients.

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

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).

Study Overview

• Status: Completed
• Conditions: Lung Collapse
• Intervention / Treatment: Procedure: HFNC group; Procedure: Standard group

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	PaO2/FIO2	First 24 postoperative hours
Atelectasis	Atelectasis evaluated with X-ray	First 24 postoperative hours

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: HFNC-Obese

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No