scholarly journals Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028098
Author(s):  
Grace Bird ◽  
Irene Braithwaite ◽  
James Harper ◽  
Steven McKinstry ◽  
Iris Koorevaar ◽  
...  
Keyword(s):  
Common Cold ◽  
Controlled Trial ◽  
High Flow ◽  
Phone Call ◽  
Upper Airways ◽  
Parallel Group ◽  
The Common ◽  
Nasal High Flow Therapy ◽  
Humidified Air ◽  
Single Blind

IntroductionThe common cold is the most common infectious disease affecting humans. It is usually a self-limiting disease; however, the common cold can cause significant morbidity and has a substantial economic impact on society. Human rhinoviruses (HRVs), which cause up to two-thirds of colds, have temperature-dependent replication and most HRV strains replicate optimally at 33°C. Delivery of heated, humidified air to the upper airways has the potential to reduce viral replication, but evidence of the effectiveness of this treatment of the common cold is inconclusive. We plan to test the hypothesis that delivery of humidified air heated to 41°C at high flow, nasal high flow rhinothermy (rNHF), for 2 hours daily for five days is more effective in reducing common cold symptom severity and duration than five days of ‘sham’ rhinothermy.Methods and analysisThis is a randomised, single-blind, parallel-group trial comparing rNHF to ‘sham’ rhinothermy in the treatment of common cold. We plan to recruit 170 participants within 48 hours of the onset of symptoms of common cold and randomise them 1:1 to receive one of the two treatments for five days. The study duration is 14 days, which includes clinic visits on the first day of randomisation and four days post-randomisation, and a phone call on the 14th day. Participants will complete daily symptom diaries which include a symptom score, the Modified Jackson Score (MJS). The primary outcome is the MJS after four days.Ethics and disseminationNew Zealand Ethics Registration: 17/STH/174. Results will be published in a peer-reviewed medical journal, presented at academic meetings, and reported to participants.Trial registration numberU1111-1194-4345 and ACTRN12617001340325; Pre-results.

scholarly journals Rhinothermy delivered by nasal high flow therapy in the treatment of the common cold: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047760
Author(s):  
Grace Bird ◽  
Irene Braithwaite ◽  
James Harper ◽  
Iris Koorevaar ◽  
Marthe van den Berg ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Common Cold ◽  
Symptom Severity ◽  
Controlled Trial ◽  
High Flow ◽  
Cold Symptom ◽  
The Common ◽  
Randomised Controlled ◽  
Humidified Air ◽  
Single Blind

BackgroundThe common cold is the most common infectious disease affecting humans and has a substantial economic impact on society. Human rhinoviruses, which cause almost two-thirds of colds, have demonstrated temperature-dependent replication which is optimal between 33°C and 35°C.MethodsThis randomised, single-blind, parallel-group trial completed at a single-centre in New Zealand, recruited 170 participants aged 18–75 years (mean age 27.5 years) who were within 48 hours of common cold symptom onset and had a symptom score (the Modified Jackson Score (MJS)) ≥7 and a negative point-of-care test for influenza. Participants were blinded to the intervention and randomised (1:1) to 5 days of either nasal high flow rhinothermy (rNHF) (100% humidified air delivered at 35 L/min and 41°C for 2 hours daily) (n=85) or ‘sham’ rhinothermy (100% humidified air delivered at 10 L/min and 31°C for 10 min daily) (n=85) and completed daily symptom diaries, which included the MJS, for 14 days, to investigate whether rNHF reduced common cold symptom severity and duration compared with ‘sham’ rhinothermy.ResultsAn intention-to-treat superiority analysis included all randomised participants and showed no difference between treatment groups for the primary outcome, the day 4 MJS analysed by analysis of covariance: mean (SD) 6.33 (3.97) for rNHF vs 5.8 (3.15) for ‘sham’; estimated difference (95% CI) 0.37 (−0.69 to 1.42), p=0.49. There was no difference in time until resolution of symptoms: mean (SD) 5.96 (4.47) days for rNHF vs 6.42 (4.09) days for ‘sham’; estimated difference (95% CI) 1.02 (0.75 to 1.38), p=0.91. There were no serious adverse events related to the study treatments.ConclusionsThis well-powered, single-blind randomised controlled trial does not provide evidence that 5 days of rNHF (100% humidified air heated to 41°C delivered at 35 L/min for 2 hours daily) reduces common cold symptom severity or duration. However, investigation of rNHF in the treatment of influenza is warranted.Trial registration numberACTRN12617001340325.

scholarly journals Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e041520
Author(s):  
Elsa Tavernier ◽  
Bairbre McNicholas ◽  
Ivan Pavlov ◽  
Oriol Roca ◽  
Yonatan Perez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Small Sample ◽  
High Flow ◽  
Occurrence Rate ◽  
Prone Positioning ◽  
Open Label ◽  
Link Type ◽  
Randomised Controlled ◽  
Nasal High Flow Therapy

IntroductionProne positioning (PP) is an effective first-line intervention to treat patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation, as it improves gas exchanges and reduces mortality. The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size. High-level evidence of awake PP for hypoxaemic patients with COVID-19 patients is still lacking.Methods and analysisThe protocol of this meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled open label superiority trials. This design is particularly adapted to a rapid scientific response in the pandemic setting. It will take place in multiple sites, among others in USA, Canada, Ireland, France and Spain. Patients will be followed up for 28 days. Patients will be randomised to receive whether awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy. Primary outcome is defined as the occurrence rate of tracheal intubation or death up to day 28. An interim analysis plan has been set up on aggregated data from the participating research groups.Ethics and disseminationEthics approvals were obtained in all participating countries. Results of the meta-trial will be submitted for publication in a peer-reviewed journal. Each randomised controlled trial was registered individually, as follows: NCT04325906, NCT04347941, NCT04358939, NCT04395144 and NCT04391140.

scholarly journals Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019350 ◽  
Author(s):  
Susanne van de Hei ◽  
Steven McKinstry ◽  
George Bardsley ◽  
Mark Weatherall ◽  
Richard Beasley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Vitamin C ◽  
Feasibility Study ◽  
Common Cold ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pcr Analysis ◽  
Control Group ◽  
The Common ◽  
Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

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