Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salvatore Maurizio MAGGIORE, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01575353
First received: December 13, 2010
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Respiratory Failure
Device: Venturi mask
Device: Nasal high-flow

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Oxygenation (PaO2/FiO2 ratio) [ Time Frame: Up to 48 hours after extubation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 hours after enrollment ] [ Designated as safety issue: No ]
    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).


Enrollment: 105
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Venturi mask
After extubation, patients will receive oxygen therapy through the standard Venturi mask (control)
Device: Venturi mask
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.
Active Comparator: Nasal high-flow
After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention)
Device: Nasal high-flow
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.
Other Name: Optiflow™

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575353

Locations
Italy
ICU, "Maggiore della Carità", University Hospital
Novara, Italy
ICU "A. Gemelli" University Hospital
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Salvatore Maurizio Maggiore, MD, PhD Catholic University of the Sacred Heart
Study Director: Massimo Antonelli, MD Catholic University of the Sacred Heart
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Salvatore Maurizio MAGGIORE, Assistant Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01575353     History of Changes
Other Study ID Numbers: 1399/10
Study First Received: December 13, 2010
Last Updated: February 27, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014