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

June 6, 2024 updated by: Tufts Medical Center

Pilot Study of Optiflow as a NIV Rest Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center
      • Winchester, Massachusetts, United States, 01890
        • Intensive Care Unit, Winchester Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optiflow
High-flow humidified nasal oxygen delivery system
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%.
Other Names:
  • Optiflow
Active Comparator: Oxygen therapy
Standard oxygen therapy
Device: Standard oxygen therapy
During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay on Noninvasive Ventilation (NIV)
Time Frame: Day 1-7
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Breaks From NIV
Time Frame: Day 4-10
This is done by having nursing staff note times of break start (off NIV) to start of next session of NIV in minutes. Subgroup analysis was performed to assess differences between hypercapnic and hypoxemic patients, not observed in terms of time spent on or off NIV.
Day 4-10
Assessment of Respiratory Rate During Break
Time Frame: day 1-4
Evaluation of respiratory rate. This was counted for a minute at bedside at start and finish of break.
day 1-4
Patients' Comfort
Time Frame: Day 2-4
Using a visual analogue scale (VAS). Patients rate how comfortable they felt on a 1 to 10 scale with 10 being most comfortable and 1 being the least comfortable.
Day 2-4
Oxygen Saturation During Breaks
Time Frame: day 1-4
Using pulse oximetry (SpO2) at beginning and end of breaks
day 1-4
Need for Intubation
Time Frame: Days 2-10
Count of participants who underwent endotracheal intubation
Days 2-10
Ease of Eating
Time Frame: Day 1-4
difficulty eating using patient rating on a visual analog scale of 0 for easy eating and 4 for difficult eating. Results tabulated as number of patients finding it easy to eat (Score of 0-1)
Day 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Nicholas S Hill, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimated)

August 19, 2013

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPH-OF13-01
  • IRB-10967 (Other Identifier: IRB Tufts Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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