Trial Outcomes & Findings for Nasal High Flow Therapy 30 Day Readmission Study (NCT NCT02552732)

Results Overview

Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

30 days after hospital discharge

Results posted on

2020-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	NHF With or Without Oxygen Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Overall Study STARTED	29
Overall Study Used Device	23
Overall Study Completed Week 1	21
Overall Study Completed Week 2	20
Overall Study Completed Week 3	19
Overall Study Completed Week 4	19
Overall Study Completed Day 1 and Day 31 Spirometry	12
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	NHF With or Without Oxygen Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	1
Overall Study Day 1 SpO2 > 96%	1
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Nasal High Flow Therapy 30 Day Readmission Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NHF With or Without Oxygen n=29 Participants NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Age, Continuous	67.34 years STANDARD_DEVIATION 10.92 • n=99 Participants
Sex: Female, Male Female	16 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Race/Ethnicity, Customized NZ European	16 Participants n=99 Participants
Race/Ethnicity, Customized Maori	1 Participants n=99 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants
Region of Enrollment New Zealand	20 participants n=99 Participants

PRIMARY outcome

Timeframe: 30 days after hospital discharge

Population: NHF use for 30 days following discharge after AECOPD. Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring.

Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
NHF Use for 30 Days Following Discharge After AECOPD	2.6560 hours per day Standard Deviation 2.4137

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home	57.6 percentage of days of use

SECONDARY outcome

Timeframe: First week after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=21 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Average Use Per Day of the myAIRVO 2 During Week 1	3.0319 hours per day Standard Deviation 3.7065

SECONDARY outcome

Timeframe: Second week after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=20 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Average Use Per Day of the myAIRVO 2 During Week 2	1.7715 hours per day Standard Deviation 2.236

SECONDARY outcome

Timeframe: Third week after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=19 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Average Use Per Day of the myAIRVO 2 During Week 3	2.0447 hours per day Standard Deviation 2.4633

SECONDARY outcome

Timeframe: Fourth week after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=19 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Average Use Per Day of the myAIRVO 2 During Week 4	2.22 hours per day Standard Deviation 2.69

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Average Use Per Day on Days of myAIRVO 2 Use	3.4326 hours per day on days of myAIRVO 2 use Standard Deviation 3.4917

SECONDARY outcome

Timeframe: At study entry

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=29 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants Using Home Oxygen	7 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow	5 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=29 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants Who Where Screened But Were Excluded From Enrollment	0 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting	9 Participants

SECONDARY outcome

Timeframe: At study completion

Number of participants who withdrew from study after enrollment, up to 30 days

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=29 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days	10 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge	2 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

AECOPD, other respiratory cause or other cause

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=2 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Reasons for Hospital Admissions AECOPD	2 Participants
Reasons for Hospital Admissions Other Respiratory	0 Participants
Reasons for Hospital Admissions Non-respiratory	0 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=2 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
In Those That Had at Least One Hospital Readmission: Number of Readmissions	1 readmission/participant

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=2 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission	26 days Standard Deviation 0

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=2 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length	1 days Standard Deviation 0

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=23 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants With at Least One ED Visit Within 30 Days of Discharge	1 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

ED visit due to AECOPD

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=1 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Reason for ED Visits	1 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=29 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Number of Participants With at Least One GP Visit Within 30 Days of Discharge	4 Participants

SECONDARY outcome

Timeframe: 30 days after hospital discharge

The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission.

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=29 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
LACE Index for Hospital Admissions	11.069 scores on a scale Standard Deviation 1.4188

SECONDARY outcome

Timeframe: 1st and 31st day after hospital discharge

FEV1 change from day 1 to day 31

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=12 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
FEV1 at Day 1 and 31	0.0042 litres per min Standard Deviation 0.1973

SECONDARY outcome

Timeframe: 1st and 31st day after hospital discharge

Slow Vital Capacity (inspiratory) change from day 1 to day 31

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=12 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
SVC(in) at Day 1 and 31	0.0027 litres per min Standard Deviation 0.393

SECONDARY outcome

Timeframe: 1st and 31st day after hospital discharge

Outcome measures

Outcome measures
Measure	NHF With or Without Oxygen n=12 Participants Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
FVC Change From Day 1 to Day 31	0.075 litres per min Standard Deviation 0.3306

Adverse Events

NHF With or Without Oxygen

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NHF With or Without Oxygen n=29 participants at risk NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
General disorders General unwellness/tired	3.4% 1/29 • Number of events 1 • Over 31 days (1 month)
General disorders Headache	3.4% 1/29 • Number of events 1 • Over 31 days (1 month)
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.3% 3/29 • Number of events 3 • Over 31 days (1 month)
Infections and infestations Oral thrush	3.4% 1/29 • Number of events 1 • Over 31 days (1 month)
Respiratory, thoracic and mediastinal disorders AECOPD	13.8% 4/29 • Number of events 4 • Over 31 days (1 month)

Additional Information

Dr Stanislav Tatkov

Fisher and Paykel Healthcare

Phone: 09 5740100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place