Episodic Hypoxemia in Mechanically Ventilated Preterm InfantsNCT01727505

Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

A study testing Sequence A: Conventional-Volume Guarantee and Sequence B: Volume Guarantee-Conventional in people with Episodic Hypoxemia in Mechanically Ventilated Preterm Infants, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspiratory pressure. Read more about this study

Who is it for?: Any age
Conditions the study is for: Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
What is being tested?: Sequence A: Conventional-Volume Guarantee and Sequence B: Volume Guarantee-Conventional
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Born at less than 32 weeks of gestational age.
Requiring mechanical ventilation on a mandatory ventilator rate greater than or equal to 20 per minute and receiving a mean tidal volume of at least 4 ml/kg.
Presenting with 4 or more episodes of hypoxemia, defined as oxygen saturation less than 75%, in the 8 hours prior to the study.

Who cannot join

Major congenital anomalies.
Hemodynamic instability requiring inotropes within 72 hours prior to the study
Culture proven sepsis within 72 hours prior to the study.
Diagnosis of pulmonary interstitial emphysema or pneumothorax within the 72 hours prior to the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System
Miami, Florida, 33136

Other trials in United States

About this study

We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by decrease in tidal volume. This is due to a reduction in respiratory system compliance and increase in airway resistance.

Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration of episodes of hypoxemia when compared to conventional mechanical ventilation during routine clinical conditions and over longer periods of time.

The objective of the study is to evaluate the effects of Volume Guarantee on the duration, severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants who present with frequent hypoxemia episodes in comparison to conventional ventilation over two periods of 24 hours each and under routine clinical conditions.

Conditions: Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
Being tested: Sequence A: Conventional-Volume Guarantee, Sequence B: Volume Guarantee-Conventional
Keywords: hypoxemia, desaturation, mechanical ventilation, preterm infants, volume guarantee ventilation
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sequence A: Conventional-Volume GuaranteeDevice
This is a crossover study. Infants will be randomly assigned to one of two sequences.
In sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation.
Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).
During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.
During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.
Sequence B: Volume Guarantee-ConventionalDevice
This is a crossover study. Infants will be randomly assigned to one of two sequences.
In sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation.
Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).
During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.
During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.

Study groups in NCT01727505
Study group	Role	What they receive
Sequence A: Conventional-Volume Guarantee	Active comparator	This is a crossover study. Infants will be assigned to one of two sequences. Sequence A consists of a 24-hour period during which the infant receives conventional mechanical ventilation followed by a second 24 hour period during which the infant receives volume guarantee ventilation. Receives: Device: Sequence A: Conventional-Volume Guarantee
Sequence B: Volume Guarantee-Conventional	Active comparator	This is a crossover study. Infants will be assigned to one of two sequences. Sequence B consists of a 24-hour period during which the infant receives volume guarantee ventilation followed by a second 24 hour period during which the infant receives conventional mechanical ventilation. Receives: Device: Sequence B: Volume Guarantee-Conventional

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time Spent With Arterial Oxygen Saturation < 75%
Percentage of time spent with arterial oxygen saturation < 75%
Measured: 24 hours

Secondary outcomes (3)

Frequency of Severe Hypoxemia Episodes
Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds.
Measured: 24 hours
Frequency of Hypoxemia Episodes
Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds
Measured: 24 hours
Duration of Hypoxemia Episodes
Duration 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Nov 2015

First posted16 Nov 2012 (estimated)
Study startNov 2012
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Episodic Hypoxemia in Mechanically Ventilated Preterm InfantsStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01727505
Sponsor's protocol ID: 20120623
Status last verified: Jan 2017
First submitted: 8 Nov 2012
Last updated: 1 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
ClinicalTrials.gov ID: NCT01727505
Acronym / sponsor ID: 20120623
Conditions: Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
Keywords: hypoxemia, desaturation, mechanical ventilation, preterm infants, volume guarantee ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Nov 2012
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 16 Nov 2012 (estimated)
Results: Posted 1 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence A: Conventional-Volume Guarantee	Active comparator	Device: Sequence A: Conventional-Volume GuaranteeThis is a crossover study. Infants will be assigned to one of two sequences. Sequence A consists of a 24-hour period during which the infant receives conventional mechanical ventilation followed by a second 24 hour period during which the infant receives volume guarantee ventilation.
Sequence B: Volume Guarantee-Conventional	Active comparator	Device: Sequence B: Volume Guarantee-ConventionalThis is a crossover study. Infants will be assigned to one of two sequences. Sequence B consists of a 24-hour period during which the infant receives volume guarantee ventilation followed by a second 24 hour period during which the infant receives conventional mechanical ventilation.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Born at less than 32 weeks of gestational age.
Requiring mechanical ventilation on a mandatory ventilator rate greater than or equal to 20 per minute and receiving a mean tidal volume of at least 4 ml/kg.
Presenting with 4 or more episodes of hypoxemia, defined as oxygen saturation less than 75%, in the 8 hours prior to the study.

Key exclusion criteria (4 listed)

Major congenital anomalies.
Hemodynamic instability requiring inotropes within 72 hours prior to the study
Culture proven sepsis within 72 hours prior to the study.
Diagnosis of pulmonary interstitial emphysema or pneumothorax within the 72 hours prior to the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sequence A: Conventional-Volume GuaranteeThis is a crossover study. Infants will be randomly assigned to one of two sequences. In sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation. Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA). During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team. During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.	Device	Sequence A: Conventional-Volume Guarantee
Sequence B: Volume Guarantee-ConventionalThis is a crossover study. Infants will be randomly assigned to one of two sequences. In sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation. Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA). During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team. During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.	Device	Sequence B: Volume Guarantee-Conventional

Primary outcome

Percentage of Time Spent With Arterial Oxygen Saturation < 75%
Time frame: 24 hours
Percentage of time spent with arterial oxygen saturation < 75%

3 secondary outcomes

Frequency of Severe Hypoxemia Episodes
Time frame: 24 hours
Frequency of Hypoxemia Episodes
Time frame: 24 hours
Duration of Hypoxemia Episodes
Time frame: 24 hours

Results and safety

Results posted to the registry on 1 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A: Conventional-Volume Guarantee	14	14
Sequence B: Volume Guarantee-Conventional	12	11

Primary outcome: Percentage of Time Spent With Arterial Oxygen Saturation < 75%

Time frame: 24 hours. Median (Inter-Quartile Range). Unit: % of time

Measure	Conventional Mechanical Ventilation Period n = 24	Volume Guarantee Ventilation Period n = 24
Value	5 (3.9 to 6.9)	4.4 (2.9 to 5)

Conventional Mechanical Ventilation Period vs Volume Guarantee Ventilation Period: p = 0.44, Wilcoxon signed rank test

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Mechanical Ventilation Period	0 of 25 (0%)	0 of 25 (0%)	Not reported
Volume Guarantee Ventilation Period	1 of 26 (3.8%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nelson Claure, M.Sc., Ph.D. principal investigator

University of Miami

Eduardo Bancalari, M.D. principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time Spent With Arterial Oxygen Saturation < 75% (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.