Tolerability of inhaled, humidified air at two temperatures (41 and 45 degrees Celsius) in healthy participants

• Register: ANZCTR
• Last refreshed on: 12 July 2021
• Main ID: ACTRN12621000853842
• Date of registration: 02/07/2021
• Prospective Registration: Yes
• Primary sponsor: Fisher & Paykel Healthcare Limited
• Public title: Tolerability of inhaled, humidified air at two temperatures (41 and 45 degrees Celsius) in healthy participants
• Scientific title: Tolerability study of rhinothermy in healthy participants delivered by nasal high flow therapy (rNHF) at 41°Celsius and 45°Celsius
• Date of first enrolment: 26/07/2021
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000853842.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Dr Karen Oldfield

• Name: Dr Karen Oldfield

Key inclusion & exclusion criteria

Inclusion criteria: Twenty healthy participants aged 18 to 75 years who are in the Investigator’s opinion, able and willing to comply with all study requirements.
Exclusion criteria: Upper respiratory tract infection (sore throat, cough, rhinorrhoea and/or fever (subjective of objective) within the last fourteen days

Chronic respiratory illness currently being treated e.g. asthma

Nasopharyngeal conditions such as a deviated septum and acute/chronic rhinitis, which the investigator considers could impair nasal breathing

Use of nasal sprays within the last seven days

Current smoker, defined as someone who has smoked or vaped within the last 28 days

Current use of or requirement of oral antibiotics for a respiratory tract infection, pneumonia or infective exacerbation of an underlying respiratory condition

Current use of or requirement of parenteral antibiotics

Have an implantable medical device

Have any other condition which, at the investigator’s discretion, is believed may present a safety risk to the participant or others, or impact the study results or the feasibility of the study.

Previous enrolment in any trials investigating the use of rhinothermy.


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Respiratory - Other respiratory disorders / diseases

Upper Respiratory Tract Infection;
Upper Respiratory Tract Infection

Intervention(s)

Three visits per subject (visits one and two may be combined at the subject request). Visits will be undertaken in person at the Medical Research Institute of New Zealand. Participants will be shown the device and the nasal cannula that is used for delivery of the intervention. They will be given the option of placing the nasal cannula on themselves or requesting the study investigator or co-ordinator to place it. All MRINZ staff delivering the intervention will be trained in device operation. During the course of the intervention a study investigator will be present observing the participant to ensure that the cannula are placed correctly and to monitor the device to ensure it is working correctly.

Participants will be randomised 1:1 to one of two groups, intervention or comparator.

Intervention: One continuous session of rhinothermy (rNHF) with 100% humidified air delivered via the rNHF (Fisher & Paykel AIRVO 3) device at 35L/min at 41o Celsius (C) for sixty minutes

The intervention may be stopped at any time by the participant.

An outline of the visits and interventions are supplied below:

Visit 1:
1. Written informed consent with collection of demographic data, medical and surgical history, concomitant medications and allergies, vital signs (heart rate, blood pressure, oxygen saturation and temperature) and a limited physical examination (chest, nose and throat).
2. Assessment for eligibility

Visit 2 (may be at the same time as Visit 1):
1. Reassessment of eligibility criteria and re-examination of the nose and throat prior to randomisation (ONLY if Visit 2 on a separate day to Visit 1).
2. Randomisation to Intervention or Comparator.
3. Delivery of Intervention or Comparator for a period of sixty minutes.

Primary Outcome(s)

Proportion of participants in each intervention/comparator group who could not tolerate rNHF for sixty minutes, as determined by review of the study database for the number of participants who stopped treatment prior to sixty minutes[Up to 60 minutes post commencement of intervention (Time 0)]

Secondary Outcome(s)

Adverse event rate in each intervention group (narrative description, examination where indicated e.g. dizziness reported, blood pressure (BP) measurement)[Up to 18- 24 hours post intervention commencement (Time 0)]

Intervention tolerability questionnaire results, adapted form previous rhinothermy studies undertaken by the Medical Research Institute of New Zealand for the purpose of this study[Within 30 minutes post-intervention completion]

Proportion of participants who stopped their intervention early for each of the identified categories on the discontinuation questionnaire, adapted form previous rhinothermy studies undertaken by the Medical Research Institute of New Zealand for the purpose of this study[Within 30 minutes post-intervention completion]

Serious adverse event rate in each intervention group (narrative description, examination where indicated)[Up to 18-24 hours post intervention commencement (Time 0)]

Time in minutes to any adverse event in each intervention arm, reported to study investigator at time of occurrence and recorded in the REDCap study database[Up to 60 minutes post commencement of intervention (Time 0)]

Time in minutes to cannula removal/tube disconnection in each intervention arm, assessed by start and stop times recorded in REDCap study database by the study investigator[Up to 60 minutes post commencement of intervention (Time 0)]

Treatment related adverse event rate (attributed by investigator as likely to be related to intervention if there is reasonable possibility of a causal relationship)[Up to 18-24 hours post intervention commencement (Time 0)]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Fisher & Paykel Healthcare Limited

Ethics review

Status: Approved
Approval date: 17/06/2021
Contact:

Central Health and Disability Ethics Committee