HFNC for Induction During Bariatric Surgery Patients.

Lung Collapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155711
• Other study ID #: HFNC-Obese
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: February 23, 2018
• Start date: May 5, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2018
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Collapse
• Pulmonary Atelectasis

Intervention

Procedure:
• HFNC group
Positive pressure plus supplemental oxygen through a high flow nasal oxygen device
• Standard group
Supplemental oxygen through venturi mask

Locations

Country	Name	City	State
Spain	Hospital clínico universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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;(8):CD008930. doi: 10.1002/14651858.CD008930.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygenation	PaO2/FIO2	First 24 postoperative hours
Secondary	Atelectasis	Atelectasis evaluated with X-ray	First 24 postoperative hours