Nasal High-flow Versus Venturi Mask Oxygen Therapy in the Post-extubation Period

NCT01575353 | Completed

• 1 other identifier: 1399/10
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Oxygenation (PaO2/FiO2 ratio)

  Arterial blood gases will be collected and the PaO2/FiO2 ratio will be measured 1, 3, 6, 12, 24, 36 and 48 hours after enrollment.

  Up to 48 hours after extubation

Secondary Outcomes (1)

• Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements

  48 hours after enrollment

Study Arms (2)

Venturi mask

ACTIVE COMPARATOR

After extubation, patients will receive oxygen therapy through the standard Venturi mask (control)

Device: Venturi mask

Nasal high-flow

ACTIVE COMPARATOR

After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention)

Device: Nasal high-flow

Interventions

Venturi mask DEVICE

The patients will receive oxygen delivered through a conventional Venturi mask. The FiO2 (color coded) will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.

Venturi mask

Nasal high-flow DEVICE

The patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set at 50l/min.

Also known as: Optiflow™

Nasal high-flow

Eligibility Criteria

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

You may qualify if:

• Mechanical ventilation \> 24h
• Successful spontaneous breathing trial conducted for a period of 30-120 min.
• PaO2/FiO2 ≤ 300 at the end of the spontaneous breathing trial preceding extubation

You may not qualify if:

• age\<18 years
• pregnancy
• tracheostomy
• need of NIV post-extubation (prophylactic NIV)

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (2)

ICU, "Maggiore della Carità", University Hospital

Novara, Novara, Italy

Location

ICU "A. Gemelli" University Hospital

Rome, Rome, 00168, Italy

Location

Related Publications (1)

• Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

  PMID: 25003980 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Salvatore Maurizio Maggiore, MD, PhD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: April 11, 2012
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

IT (2)