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

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ClinicalTrials.gov Identifier: NCT01575353
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Salvatore Maurizio MAGGIORE, Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE December 13, 2010
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Oxygenation (PaO2/FiO2 ratio) [ Time Frame: Up to 48 hours after extubation ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • Oxygenation, patient's discomfort [ Time Frame: 1 hour after enrollment ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation, discomfort [ Time Frame: 3 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation, discomfort [ Time Frame: 6 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation, discomfort [ Time Frame: 12 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation,discomfort [ Time Frame: 24 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation,discomfort [ Time Frame: 36 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
  • oxygenation,discomfort [ Time Frame: 48 hours ]
    Arterial blood gases, patient's discomfort, and respiratory variables will be recorded 1, 3, 6, 12, 24, 36 and 48 hours after enrollment. 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).
Change History Complete list of historical versions of study NCT01575353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements [ Time Frame: 48 hours after enrollment ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
Need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements [ Time Frame: 48 hours after enrollment ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasal High-flow Versus Venturi Mask Oxygen Therapy in the Post-extubation Period
Official Title  ICMJE Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Respiratory Failure
Intervention  ICMJE
  • 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.
  • 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™
Study Arms  ICMJE
  • Active Comparator: Venturi mask
    After extubation, patients will receive oxygen therapy through the standard Venturi mask (control)
    Intervention: Device: Venturi mask
  • Active Comparator: Nasal high-flow
    After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention)
    Intervention: Device: Nasal high-flow
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575353
Other Study ID Numbers  ICMJE 1399/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Salvatore Maurizio MAGGIORE, Catholic University of the Sacred Heart
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Salvatore Maurizio Maggiore, MD, PhD Catholic University of the Sacred Heart
Study Director: Massimo Antonelli, MD Catholic University of the Sacred Heart
PRS Account Catholic University of the Sacred Heart
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP