Trial Outcomes & Findings for Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation (NCT NCT01925534)
NCT ID: NCT01925534
Last Updated: 2024-07-03
Results Overview
The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Day 1-7
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Optiflow
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation
Baseline characteristics by cohort
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 14.0 • n=107 Participants
|
66.17 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
24 participants
n=107 Participants
|
47 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1-7The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Length of Stay on Noninvasive Ventilation (NIV)
|
1404 Minutes
Standard Deviation 1386
|
1386 Minutes
Standard Deviation 951
|
SECONDARY outcome
Timeframe: Day 4-10This is done by having nursing staff note times of break start (off NIV) to start of next session of NIV in minutes. Subgroup analysis was performed to assess differences between hypercapnic and hypoxemic patients, not observed in terms of time spent on or off NIV.
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Length of Breaks From NIV
|
1345 minutes
Standard Deviation 902
|
1221 minutes
Standard Deviation 770
|
SECONDARY outcome
Timeframe: day 1-4Population: Two groups randomly allocated to High Flow or Standard oxygen therapy
Evaluation of respiratory rate. This was counted for a minute at bedside at start and finish of break.
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Assessment of Respiratory Rate During Break
Respiratory Rate: Break
|
23.8 breaths/min
Standard Deviation 6.8
|
21.8 breaths/min
Standard Deviation 5.2
|
|
Assessment of Respiratory Rate During Break
Respiratory Rate: NIV
|
23.3 breaths/min
Standard Deviation 5.3
|
20.1 breaths/min
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Day 2-4Using a visual analogue scale (VAS). Patients rate how comfortable they felt on a 1 to 10 scale with 10 being most comfortable and 1 being the least comfortable.
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Patients' Comfort
VAS Comfort Score Break
|
8.3 score on a scale
Standard Deviation 2.7
|
6.9 score on a scale
Standard Deviation 2.3
|
|
Patients' Comfort
VAS Comfort Score NIV
|
5.9 score on a scale
Standard Deviation 3.9
|
6.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: day 1-4Using pulse oximetry (SpO2) at beginning and end of breaks
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Oxygen Saturation During Breaks
SpO2, % mean: Break
|
94.1 arterial oxygen saturation (%)
Standard Deviation 3.2
|
94.7 arterial oxygen saturation (%)
Standard Deviation 2.1
|
|
Oxygen Saturation During Breaks
SpO2, % final: Break
|
93.7 arterial oxygen saturation (%)
Standard Deviation 5.0
|
95.4 arterial oxygen saturation (%)
Standard Deviation 2.7
|
|
Oxygen Saturation During Breaks
SpO2, % final: NIV
|
95.9 arterial oxygen saturation (%)
Standard Deviation 2.9
|
96.4 arterial oxygen saturation (%)
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Days 2-10Count of participants who underwent endotracheal intubation
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Need for Intubation
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1-4difficulty eating using patient rating on a visual analog scale of 0 for easy eating and 4 for difficult eating. Results tabulated as number of patients finding it easy to eat (Score of 0-1)
Outcome measures
| Measure |
Optiflow
n=23 Participants
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 Participants
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Ease of Eating
|
20 Participants
|
15 Participants
|
Adverse Events
Optiflow
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Oxygen Therapy
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Optiflow
n=23 participants at risk
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 participants at risk
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
endotracheal intubation (ETI)
|
8.7%
2/23
|
0.00%
0/24
|
Other adverse events
| Measure |
Optiflow
n=23 participants at risk
High-flow humidified nasal oxygen delivery system
High-flow humidified nasal oxygen delivery system: During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
|
Oxygen Therapy
n=24 participants at risk
Standard oxygen therapy
Standard oxygen therapy: During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
|
|---|---|---|
|
Ear and labyrinth disorders
Nasal Dryness
|
47.8%
11/23 • Number of events 11
|
62.5%
15/24 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place