Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation

Acute Respiratory Failure Clinical Trial

— OPTINIV  

Official title:

Pilot Study of Optiflow as a NIV Rest Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925534
• Other study ID #: FPH-OF13-01
• Secondary ID: IRB-10967
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: January 19, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Treatment With Noninvasive Positive Pressure Ventilation

Intervention

Device:
• High-flow humidified nasal oxygen delivery system
During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
• Standard oxygen therapy
During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.

Locations

Country	Name	City	State
United States	Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center	Boston	Massachusetts
United States	Intensive Care Unit, Winchester Hospital	Winchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bräunlich 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. — View 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. — View Citation

El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. — View Citation

Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. — View 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. — View 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. — View Citation

Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay on NIV	The investigator will measure the total time on NIV in day(s), hours and minutes	Day 4-10
Secondary	NIV-related complications		day 4-10
Secondary	Length of breaks from NIV		Day 4-10
Secondary	Assessment of respiratory distress	Evaluation of respiratory distress through respiratory rate, dyspnea score using Borg scale and accessory muscle use	day 2-4
Secondary	Patients' comfort	Using a visual analogue scale (VAS)	Day 2-4
Secondary	Gas exchange during breaks	Using SpO2 and transcutaneous CO2	day 2-4
Secondary	NIV failure		day 2-10
Secondary	Need for intubation		Days 2-10
Secondary	Ease of eating		Day 2-4