Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000414617
Ethics application status
Approved
Date submitted
18/03/2014
Date registered
16/04/2014
Date last updated
16/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The tolerability and level of discomfort of 15 lpm vs 6 lpm oxygen through a normal nasal cannula
Scientific title
Study of healthy volunteer's ability to tolerate high-flow (15 lpm) vs low--flow (6 lpm) of non-humidified, non-heated, nasal oxygen through a normal nasal cannula for 10-minutes.
Secondary ID [1] 284284 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia 291421 0
Intubation 291422 0
Rapid Sequence Intubation (RSI) 291423 0
Procedural Sedation and Analgesia (PSA) 291424 0
Apneic oxygenation 291425 0
Apnea 291426 0
Condition category
Condition code
Anaesthesiology 291790 291790 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-flow non-humidified, non-warmed, nasal oxygen at rates of 15 lpm through a normal nasal cannula for 10 minutes.

There is a washout period of at least 1 hour between trial flow-rates before cross-over
Intervention code [1] 288998 0
Treatment: Devices
Comparator / control treatment
low-flow non-humidified, non-warmed, nasal oxygen at rates of 6 lpm through a normal nasal cannula for 10 minutes.

There is a washout period of at least 1 hour between trial flow-rates before cross-over.

For example, about half of the participants will receive 10 minutes of higher-flow oxygen, wait for 1 hour, then receive 10 minutes of lower-flow oxygen.
Control group
Dose comparison

Outcomes
Primary outcome [1] 291713 0
The ability to tolerate 10-minutes of high-flow NC oxygen. This is a binary outcome (success or failure)
Timepoint [1] 291713 0
10-minutes
Secondary outcome [1] 307342 0
The difference in discomfort from high-flow and low-flow NC oxygen at 5 and 10-minutes and 1 minute after the NC is removed as measured on a VAS scale.
Timepoint [1] 307342 0
5, 10, and 1 minute after the NC is removed.

Eligibility
Key inclusion criteria
Healthy volunteers who worked in our hospital.
Minimum age
19 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous participation in study
recent history of nasal trauma
history of significant respiratory disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomized to order of intervention (high-flow first followed by low-flow 1 hour later verses low-flow first followed by high flow) by selecting a a slip of paper out of an opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The binary randomisation sequence was written on slips of paper.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Although we attempted to blind the subjects from knowing which flow rate they recieved, most subjects we easily able to determine which flow rate there were recieving.
Phase
Type of endpoint/s
Safety
Statistical methods / analysis
Primary:
100% of the subjects are expected to tolerate the NC at 6 lpm, it for the duration of the study.

It is hypothesized that no less than 90% of the participants will be able to tolerate the high-flow non-humidified oxygen for five and ten minutes.

This gives us a non-inferior margin of 10% to be considered as a clinical relevant difference for comparison between the high-flow vs. the ordinal 6 lpm

Base on simulations, 100 samples will result in a precision level for the targeted non-inferior margin of 10%, given a 100% tolerance to completion rate for the high-flow group.

Secondary:

Considering a non-inferior margin of 17 mm and using the previously reported minimally clinically significant differences in VAS of greater than or equal to 17 mm we expect that 95% of participants will have a difference of less than 17mm between two repeated measures of patients.

Literature has reported that a 17mm change in VAS rating for pain is a clinically significant difference in pain. We believe that a change of greater than or equal to 17mm is also a clinically significant difference in discomfort.

Our power calculation assumes a maximal standard deviation of the measured difference between VAS is 20mm. Our sample size simulations show that a sample size of 50 subjects will allow us to measure a non-inferior VAS interval of 3.8mm-10.3mm and a 4%-12% for difference in the tolerability outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2014
Actual
7/01/2014
Date of last participant enrolment
Anticipated
7/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5901 0
New Zealand
State/province [1] 5901 0
Auckland

Funding & Sponsors
Funding source category [1] 288911 0
Hospital
Name [1] 288911 0
Middlemore Hospital
Country [1] 288911 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
100 Hospital Rd, Papatoetoe 2025
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287607 0
None
Name [1] 287607 0
Address [1] 287607 0
Country [1] 287607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290741 0
Ko Awatea Research Office
Ethics committee address [1] 290741 0
Ko Awatea Research Office
Counties Manukau DHB
Clinical Support Building
Room 253, Level 2
Middlemore Hospital
100 Hospital Rd, Papatoetoe 2025
New Zealand
Ethics committee country [1] 290741 0
New Zealand
Date submitted for ethics approval [1] 290741 0
Approval date [1] 290741 0
30/09/2013
Ethics approval number [1] 290741 0

Summary
Brief summary
Objectives: To determine the tolerability and level of discomfort from higher flow, non-humidified oxygen through a normal nasal cannula (NC) in healthy volunteers.
Background
Although high-flow non-humidified nasal oxygen at rates of up to 15 lpm is now recommended as a method to provide apneic oxygenation during intubation, many older sources suggest that flow-rates greater than 6 lpm can cause patient discomfort. , , To our knowledge, there is no evidence on the ability of subjects to tolerate high-flow NC and this trial will be the first research that evaluates the ability of subjects tolerate high-flow nasal oxygen through a normal NC.

Methods:
This prospective, double blinded, interventional, non-inferiority crossover study will be conducted in the Emergency Department (ED), Middlemore Hospital from December 2013 to June 2014.

Subjects will be randomized and blinded to first receive either low-flow (6 lpm), or high-flow (15 lpm) of oxygen through NC for a maximum of 10-minutes (completion) or until the subject deems it intolerable. After at least a 1-hour washout period, subjects will then trial the alternative flow-rate.

Populations
The potential subjects include staff members working in Middlemore Hospital. No patients will be enrolled.

The exclusion criteria will be previous participation in study, recent history of nasal trauma, or history of significant respiratory disease.

Results
The primary outcome will be the subject’s ability to tolerate each flow-rate at ten minutes. We believe 100% of subjects will tolerate 10-mintues of the low-flow NC and that no less than 90% will tolerate 10-minutes of high-flow NC.

Other outcomes will be the difference in duration that the subject tolerates the NC as measured in seconds before the subject removes the NC. We hypothesize there will be less than one minute of difference between the flow-rates.

Another outcome will be the subject’s discomfort as reported on a 100mm visual analog scale at each flow rate. A difference of 17mm will be considered clinically significant. We believe there will be a clinically significant difference of greater than 17mm between the two flow-rates.

Other recorded outcomes will include the vital signs, symptoms of discomfort, and a description of a brief nasal exam on subjects reporting significant symptoms. We believe that there will be minimal differences in these other variables.

Conclusions
We predict that most subjects will be able to tolerate 10-minutes of high-flow nasal oxygen without meaningful discomfort.
Trial website
Trial related presentations / publications
Public notes
Objectives: To determine the tolerability and level of discomfort from higher flow, non-humidified oxygen through a normal nasal cannula (NC) in healthy volunteers.
Background
Although high-flow non-humidified nasal oxygen at rates of up to 15 lpm is now recommended as a method to provide apneic oxygenation during intubation, many older sources suggest that flow-rates greater than 6 lpm can cause patient discomfort. , , To our knowledge, there is no evidence on the ability of subjects to tolerate high-flow NC and this trial will be the first research that evaluates the ability of subjects tolerate high-flow nasal oxygen through a normal NC.

Methods:
This prospective, double blinded, interventional, non-inferiority crossover study will be conducted in the Emergency Department (ED), Middlemore Hospital from December 2013 to June 2014.

Subjects will be randomized and blinded to first receive either low-flow (6 lpm), or high-flow (15 lpm) of oxygen through NC for a maximum of 10-minutes (completion) or until the subject deems it intolerable. After at least a 1-hour washout period, subjects will then trial the alternative flow-rate.

Populations
The potential subjects include staff members working in Middlemore Hospital. No patients will be enrolled.

The exclusion criteria will be previous participation in study, recent history of nasal trauma, or history of significant respiratory disease.

Results
The primary outcome will be the subject’s ability to tolerate each flow-rate at ten minutes. We believe 100% of subjects will tolerate 10-mintues of the low-flow NC and that no less than 90% will tolerate 10-minutes of high-flow NC.

Other outcomes will be the difference in duration that the subject tolerates the NC as measured in seconds before the subject removes the NC. We hypothesize there will be less than one minute of difference between the flow-rates.

Another outcome will be the subject’s discomfort as reported on a 100mm visual analog scale at each flow rate. A difference of 17mm will be considered clinically significant. We believe there will be a clinically significant difference of greater than 17mm between the two flow-rates.

Other recorded outcomes will include the vital signs, symptoms of discomfort, and a description of a brief nasal exam on subjects reporting significant symptoms. We believe that there will be minimal differences in these other variables.

Conclusions
We predict that most subjects will be able to tolerate 10-minutes of high-flow nasal oxygen without meaningful discomfort.
Attachments [1] 1 1 0 0
/AnzctrAttachments/365992-1658 Brainard - institutional approval.pdf

Contacts
Principal investigator
Name 47026 0
Dr Andrew Brainard
Address 47026 0
Middlemore Hospital
Emergency Care
100 Hospital Rd, Papatoetoe 2025
Country 47026 0
New Zealand
Phone 47026 0
+64 212467423
Fax 47026 0
Email 47026 0
andrew.brainard@middlemore.co.nz
Contact person for public queries
Name 47027 0
Dr Andrew Brainard
Address 47027 0
Middlemore Hospital
Emergency Care
100 Hospital Rd, Papatoetoe 2025
Country 47027 0
New Zealand
Phone 47027 0
+64 212467423
Fax 47027 0
Email 47027 0
andrew.brainard@middlemore.co.nz
Contact person for scientific queries
Name 47028 0
Dr Andrew Brainard
Address 47028 0
Middlemore Hospital
Emergency Care
100 Hospital Rd, Papatoetoe 2025
Country 47028 0
New Zealand
Phone 47028 0
+64 212467423
Fax 47028 0
Email 47028 0
andrew.brainard@middlemore.co.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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