NCT01925534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

July 31, 2013

Results QC Date

November 15, 2021

Last Update Submit

June 6, 2024

Conditions

Acute Respiratory FailureTreatment With Noninvasive Positive Pressure Ventilation

Keywords

OptiflowHumidified high-flow oxygen therapyNoninvasive ventilationAcute respiratory failureStandard oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Length of Stay on Noninvasive Ventilation (NIV)

    The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.

    Day 1-7

Secondary Outcomes (6)

  • Length of Breaks From NIV

    Day 4-10

  • Assessment of Respiratory Rate During Break

    day 1-4

  • Patients' Comfort

    Day 2-4

  • Oxygen Saturation During Breaks

    day 1-4

  • Need for Intubation

    Days 2-10

  • +1 more secondary outcomes

Study Arms (2)

Optiflow

EXPERIMENTAL

High-flow humidified nasal oxygen delivery system

Device: High-flow humidified nasal oxygen delivery system

Oxygen therapy

ACTIVE COMPARATOR

Standard oxygen therapy

Device: Standard oxygen therapy

Interventions

High-flow humidified nasal oxygen delivery systemDEVICE

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%.

Also known as: Optiflow
Optiflow
Standard oxygen therapyDEVICE

During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.

Oxygen therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Intensive Care Unit, Winchester Hospital

Winchester, Massachusetts, 01890, United States

Location

Related Publications (8)

  • 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.

    PMID: 19294364BACKGROUND

  • 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.

    PMID: 23013907BACKGROUND

  • 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.

    PMID: 21946925BACKGROUND

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

    PMID: 20406507BACKGROUND

  • 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. Epub 2011 Apr 15.

    PMID: 21496369BACKGROUND

  • 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.

    PMID: 21908497BACKGROUND

  • 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.

    PMID: 21255498BACKGROUND

  • 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.

    PMID: 23128844BACKGROUND

Results Point of Contact

Title
Dr. Nicholas Hill
Organization
Tufts Medical Center
nhill@tuftsmedicalcenter.org
(617) 636-6377

Study Officials

  • Nicholas S Hill, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 19, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2016

Last Updated

July 3, 2024

Results First Posted

July 3, 2024

Record last verified: 2024-06

Locations

US(2)