Trial Outcomes & Findings for Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia (NCT NCT01727505)
NCT ID: NCT01727505
Last Updated: 2017-03-01
Results Overview
Percentage of time spent with arterial oxygen saturation \< 75%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
24 hours
Results posted on
2017-03-01
Participant Flow
This study was conducted at the Project NewBorn Neonatal Intensive Care Unit of the Jackson Memorial Hospital/University of Miami Medical Center. Subjects were recruited into the study between December, 2012 and September, 2014.
42 infants were screened. Of these, 9 declined participation and 3 did not meet inclusion criteria. 30 infants were enrolled (consented). Of these, 4 infants became ineligible after consent and were not studied. 26 enrolled infants were studied.
Participant milestones
| Measure |
Sequence A: Conventional-Volume Guarantee
This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation.
|
Sequence B: Volume Guarantee-Conventional
This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation.
|
|---|---|---|
|
First 24 Hours
STARTED
|
14
|
12
|
|
First 24 Hours
COMPLETED
|
14
|
11
|
|
First 24 Hours
NOT COMPLETED
|
0
|
1
|
|
Second 24 Hours
STARTED
|
14
|
11
|
|
Second 24 Hours
COMPLETED
|
14
|
10
|
|
Second 24 Hours
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence A: Conventional-Volume Guarantee
This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation.
|
Sequence B: Volume Guarantee-Conventional
This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation.
|
|---|---|---|
|
First 24 Hours
Adverse Event
|
0
|
1
|
|
Second 24 Hours
Missing data
|
0
|
1
|
Baseline Characteristics
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Baseline characteristics by cohort
| Measure |
Study Population
n=24 Participants
This is a crossover study. Infants were randomly assigned to one of two sequences.
Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.
Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation.
|
|---|---|
|
Age, Continuous
|
32 days
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
|
Gestational age
|
25 weeks
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Birth weight
|
685 grams
STANDARD_DEVIATION 216 • n=5 Participants
|
|
Ventilator mandatory rate
|
33 breaths per minute
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Peak inspiratory pressure
|
19.4 cm H2O
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Pressure support
|
10.4 cm H2O
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Positive end expiratory pressure
|
5.3 cm H2O
STANDARD_DEVIATION 0.47 • n=5 Participants
|
|
Fraction of Inspired Oxygen
|
0.38 fraction
STANDARD_DEVIATION 0.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPercentage of time spent with arterial oxygen saturation \< 75%
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Percentage of Time Spent With Arterial Oxygen Saturation < 75%
|
5 % of time
Interval 3.9 to 6.9
|
4.4 % of time
Interval 2.9 to 5.0
|
SECONDARY outcome
Timeframe: 24 hoursFrequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 \< 75% lasting for at least 20 seconds.
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Frequency of Severe Hypoxemia Episodes
|
2.1 severe hypoxemia episodes per hour
Interval 1.3 to 2.6
|
1.9 severe hypoxemia episodes per hour
Interval 1.1 to 2.5
|
SECONDARY outcome
Timeframe: 24 hoursFrequency of hypoxemia episodes defined as episodes with arterial saturation \< 85% for at least 20 seconds
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Frequency of Hypoxemia Episodes
|
6.8 hypoxemia episodes per hour
Interval 4.6 to 7.9
|
6.5 hypoxemia episodes per hour
Interval 5.6 to 8.9
|
SECONDARY outcome
Timeframe: 24 hoursDuration of hypoxemia episodes of arterial saturation \< 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Duration of Hypoxemia Episodes
|
76 seconds
Interval 70.0 to 92.0
|
73 seconds
Interval 65.0 to 81.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursCalculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods. Reported as median and inter-quartile range of all subjects.
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Fraction of Inspired Oxygen (FiO2)
|
.42 fraction
Interval 0.37 to 0.53
|
.41 fraction
Interval 0.36 to 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursThe mean exhaled tidal volume of mechanical breaths.
Outcome measures
| Measure |
Conventional Mechanical Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
Volume Guarantee Ventilation Period
n=24 Participants
This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random.
|
|---|---|---|
|
Tidal Volume
|
6.2 ml/Kg
Standard Deviation 1.6
|
5.6 ml/Kg
Standard Deviation 0.7
|
Adverse Events
Conventional Mechanical Ventilation Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Volume Guarantee Ventilation Period
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Mechanical Ventilation Period
n=25 participants at risk
This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
These data represent the 24 hours of Conventional Mechanical Ventilation.
|
Volume Guarantee Ventilation Period
n=26 participants at risk
This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
These data represent the 24 hours of Volume Guarantee Ventilation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Increased PaCO2 requiring high frequency ventilation
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Nelson Claure, MSc, PhD, Director Neonatal Pulmonary Research Lab
University of Miami School of Medicine, Dept. of Pediatrics - Div. of Neonatology
Phone: 305 585 6408
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place