The effect of rhinothermy on nasopharyngeal temperature

Not Applicable

• Conditions: Respiratory viruses; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000064909
• Lead Sponsor: Fisher and Paykel Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-24
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Aged 18-75 years inclusive
•In the Investigator’s opinion, is able and willing to comply with all trial requirements

Exclusion Criteria

•Any respiratory condition including but not limited to asthma, COPD, bronchiectasis and pulmonary fibrosis

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

•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

•A notifiable disease e.g. Tuberculosis or Human Immunodeficiency Virus

•Current use of anticoagulant medication

•Previous sinus surgery

•An episode of epistaxis during the last week

•Pre-existing bleeding disorder

•Neurological or neuromuscular conditions which could cause disorders of breathing, swallowing or posture

•Previous allergic reaction to local anaesthetic

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean nasopharyngeal temperature during delivery of rNHF at 41°C whilst nose breathing as measured by the nasopharyngeal temperature probe.<br><br>Nasal endoscopy will be performed by a doctor trained and competent in the procedure. Prior to administering any interventions a doctor will administer local anaesthetic spray to the participant’s nostrils and nasopharynx. Once anaesthetised, a temperature probe (thermistor) will be inserted via the nares into the participant’s nasopharynx by a doctor under direct visualisation using a flexible nasoendoscope. Once the temperature probe position is confirmed in the nasopharynx, there will be a five minute period of monitoring to confirm correct read outs from the temperature probe, and obtain the baseline nasopharyngeal temperature.[During the five minute recording period for nose breathing ]