Clinical trial NCT01925534: Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation
Official title: Pilot Study of Optiflow as a NIV Rest Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Treatment With Noninvasive Positive Pressure Ventilation
Keywords: Optiflow
Humidified high-flow oxygen therapy
Noninvasive ventilation
Acute respiratory failure
Standard oxygen therapy
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2013-08-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. The investigators anticipate that the Optiflow will provide oxygen more effectively, be more comfortable and permit longer breaks off NIV, shortening the total duration of NIV.

Detailed description: Background: Noninvasive ventilation (NIV) provides respiratory support to many patients affected by acute respiratory failure. This treatment, compared to invasive mechanical ventilation, allows patients to take intermittent breaks during which oxygen therapy is provided through a nasal cannula or mask. During these breaks, the lack of ventilator support may predispose to respiratory distress, retention of CO2 and oxygen desaturation. Optiflow is a nasal humidified (37◦C, 44mg/L H2O) high-flow (up to 60 L/min) therapy which can provide greater support than standard oxygen therapy during the breaks from NIV.

Aim of the study is to evaluate Optiflow as an alternative to standard oxygen therapy during breaks from NIV in patients with acute respiratory failure. The investigators hypothesize tha Optiflow will reduce the total length of stay on NIV, and increase the comfort and length of the breaks. Also, the investigators anticipate that it will reduce respiratory rate, accessory muscle use and dyspnea score compared to standard oxygen therapy.

Experimental design Prospective open-label, parallel, randomized (1:1) controlled study, with a target enrollment of 70.

Study procedures Enrolled patients receiving NIV will be randomized into two arms; a treatment group which will receive Optiflow during breaks and a control arm which will receive standard oxygen therapy during breaks. In both cases, FiO2 will be titrated to maintain oxygen saturation above 90%. The necessity of breaks will be determined together with the patients (talk, eat, medication, communicate with family, inability to tolerate the interface), and the need to resume NIV will be based on clinical data, such as dyspnea, respiratory rate, heart rate, blood pressure, oxygen saturation, transcutaneous carbon dioxide (CO2) and patients' desire.

Recorded data: The investigators will record demographic baseline data; Glasgow Coma Scale, respiratory and heart rate, blood pressure, dyspnea score, accessory muscle use, and comfort score at randomization, at the end of each NIV session and NIV break; the length of each NIV session and break; the medications administered and all the arterial blood gases (ABG) on a daily basis. Moreover the investigators will record the NIV parameters and inspired oxygen fraction (FiO2) at each session and break.

Risks: The investigators don't anticipate any significant risks related to the study procedures and equipment. Some patients may not tolerate the Optiflow and some patients may fail NIV and require intubation.

Eligibility criteria: Inclusion Criteria:

* Patients of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.
* Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH \<7.35 and arterial CO2 \> 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or
* Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio \< 300 and respiratory rate ≥ 24.
* Anticipated duration on NIV of at least 24 hrs

Exclusion criteria:

* Usual contraindications to NIV
* Respiratory arrest
* Unable to fit mask
* Medically unstable or multiple organ failure or unstable coronary disease
* Agitated or uncooperative
* Unable to protect airways
* Swallowing difficulties
* Excessive secretions not managed by clearance techniques
* Recent upper airway or gastro-intestinal surgery
* Facial deformity or previous head and neck surgery
* Undrained pneumothorax
* NIV failure within first 2 hours (either intolerance or requirement for intubation)
* Managed for greater than 48 hours on NIV prior to randomization
* Disorientation, confusion, unable to rate comfort or dyspnea
* Expected to require NIV for fewer than 24 hrs from the time of enrollment
* Patient previously in study
* Patients on CPAP nighttime only due to OSA

Withdrawal/Termination criteria:

* Patients will be withdrawn from the study when NIV fails and/or the patient is intubated.

Primary outcomes:
measure: Length of Stay on Noninvasive Ventilation (NIV)
timeFrame: Day 1-7
Secondary outcomes:
measure: Length of Breaks From NIV
timeFrame: Day 4-10
measure: Assessment of Respiratory Rate During Break
timeFrame: day 1-4
measure: Patients' Comfort
timeFrame: Day 2-4
measure: Oxygen Saturation During Breaks
timeFrame: day 1-4
measure: Need for Intubation
timeFrame: Days 2-10
measure: Ease of Eating
timeFrame: Day 1-4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center
state: Massachusetts
city: Winchester
country: United States
facility: Intensive Care Unit, Winchester Hospital
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Nicholas S Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ricard JD, Boyer A. Humidification during oxygen therapy and non-invasive ventilation: do we need some and how much? Intensive Care Med. 2009 Jun;35(6):963-5. doi: 10.1007/s00134-009-1457-9. Epub 2009 Mar 18. No abstract available.
citation: El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.
citation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
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citation: Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
citation: Parke RL, McGuinness SP, Eccleston ML. A preliminary randomized controlled trial to assess effectiveness of nasal high-flow oxygen in intensive care patients. Respir Care. 2011 Mar;56(3):265-70. doi: 10.4187/respcare.00801. Epub 2011 Jan 21.
citation: Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.