Trial Outcomes & Findings for Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants (NCT NCT03137225)
NCT ID: NCT03137225
Last Updated: 2019-11-12
Results Overview
The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.
TERMINATED
NA
1 participants
8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
2019-11-12
Participant Flow
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Participant milestones
| Measure |
NIPPV Then NAVA Mode
After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.
These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.
One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)
|
NAVA Then NIPPV Mode
After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.
One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode.
|
|---|---|---|
|
First 4 Hour Measurement Period
STARTED
|
1
|
0
|
|
First 4 Hour Measurement Period
COMPLETED
|
1
|
0
|
|
First 4 Hour Measurement Period
NOT COMPLETED
|
0
|
0
|
|
Second 4 Hour Measurement Period
STARTED
|
1
|
0
|
|
Second 4 Hour Measurement Period
COMPLETED
|
1
|
0
|
|
Second 4 Hour Measurement Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Baseline characteristics by cohort
| Measure |
NIPPV Then NAVA Mode
n=1 Participants
After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode.
These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, at the same PEEP (positive end-expiratory pressure) and respiratory rate.
One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)
|
NAVA Then NIPPV Mode
After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , at the same PEEP (positive end-expiratory pressure) and respiratory rate.
One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
|
Sex: Female, Male
Male
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Synchronicity from the ventilator at the time of an event. This will be analyzed to determine whether asynchronicity is related to increased number of events during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During each four hour treatment segmentPopulation: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Overall asynchronicity counts will be determined by ventilator data that can be uploaded and analyzed with software supplied by the manufacturer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Average mean airway pressure and peak inspiratory pressures required in each mode of ventilation.
Outcome measures
Outcome data not reported
Adverse Events
NIPPV Then NAVA Mode
NAVA Then NIPPV Mode
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place