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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Venturi mask
Nasal high-flow
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • ICU, "Maggiore della Carità", University Hospital
  • ICU "A. Gemelli" University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Venturi mask

Nasal high-flow

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements
Patient's discomfort, the need and causes for non-invasive ventilation or endotracheal intubation, episodes of oxygen desaturation (defined as SpO2 < 92% or < 88% in hypercapnic patients with chronic obstructive pulmonary disease) and episodes of displacement of the device for oxygen delivery (as estimated by nurses) will be recorded in the 48h study period. Patient's discomfort related to the device used for oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 0 (no discomfort) to 10 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).

Full Information

First Posted
December 13, 2010
Last Updated
February 27, 2014
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01575353
Brief Title
Nasal High-flow Versus Venturi Mask Oxygen Therapy in the Post-extubation Period
Official Title
Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Acute respiratory failure is one the most common reason for admission and mechanical ventilation is the most frequent procedure performed in the intensive care unit (ICU). After extubation, oxygen therapy is commonly used to correct residual impairment in oxygenation. Oxygen therapy is usually performed via a Venturi mask allowing to deliver predetermined oxygen concentrations. The face mask is used in the place of nasal cannula in part because patients with acute respiratory failure (ARF) breath preferentially through an open mouth rather than the nose. The mask may, however, reduce comfort and patients with ARF, who are often agitated and poorly cooperative, may displace or self-remove the mask. Given that oxygen delivered to the patient is dry, clinical practice guidelines recommend humidifying the oxygen when above 4 l/min in the ICU setting, because the humidification function of the nasal mucosa can be insufficient at high oxygen flow rates and/or the critically ill patient with ARF often breathes through the mouth. Breathing dry oxygen could provoke dryness of the mouth, nose, throat and respiratory tract, resulting in discomfort and pain that are frequent in the ICU setting. Breathing dry air by the nose may also lead to the alteration of the mucociliary transport system and cause an increase of airway resistance in healthy subjects. However, there are no recommendations concerning the type of humidification device to use. High-flow oxygen therapy is commonly practiced in the ICU. Recently, a method was described in which high-flow oxygen is delivered through a nasal cannula with an active humidification system that optimizes oxygen administration in patients with ARF (Optiflow, Fisher & Paykel, New Zealand). This system has several theoretical advantages. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD. Lastly, the use of high humidity levels may prevent damage to the ciliated epithelium of the airways, maintain mucociliary system activity, and facilitate the elimination of secretions. Through these effects, this new device for high-flow oxygen therapy has the potential to be effective and to improve tolerance to the treatment more than conventional systems for oxygen therapy, such as the Venturi mask. In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, nasal high-flow oxygen therapy and the standard Venturi mask, in critically ill patients who need oxygen in the post-extubation period. The hypothesis is that nasal high-flow is superior to the Venturi mask in terms of oxygenation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venturi mask
Arm Type
Active Comparator
Arm Description
After extubation, patients will receive oxygen therapy through the standard Venturi mask (control)
Arm Title
Nasal high-flow
Arm Type
Active Comparator
Arm Description
After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention)
Intervention Type
Device
Intervention Name(s)
Venturi mask
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nasal high-flow
Other Intervention Name(s)
Optiflow™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygenation (PaO2/FiO2 ratio)
Description
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.
Time Frame
Up to 48 hours after extubation
Secondary Outcome Measure Information:
Title
Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements
Description
Patient's discomfort, the need and causes for non-invasive ventilation or endotracheal intubation, episodes of oxygen desaturation (defined as SpO2 < 92% or < 88% in hypercapnic patients with chronic obstructive pulmonary disease) and episodes of displacement of the device for oxygen delivery (as estimated by nurses) will be recorded in the 48h study period. Patient's discomfort related to the device used for oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 0 (no discomfort) to 10 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).
Time Frame
48 hours after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: age<18 years pregnancy tracheostomy need of NIV post-extubation (prophylactic NIV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Maurizio Maggiore, MD, PhD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Antonelli, MD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Study Director
Facility Information:
Facility Name
ICU, "Maggiore della Carità", University Hospital
City
Novara
Country
Italy
Facility Name
ICU "A. Gemelli" University Hospital
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25003980
Citation
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.
Results Reference
derived

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

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