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Flow-synchronized Nasal IMV in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02085499
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Nelson Claure, University of Miami

Brief Summary:

The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.

The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.

The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.

This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.

The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.

The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.


Condition or disease Intervention/treatment Phase
Premature Infants Requiring Non-invasive Respiratory Support Device: non-synchronized NIMV Device: Synchronized NIMV Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
NIMV followed by S-NIMV
During the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV.
Device: non-synchronized NIMV

During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute.

NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO).


Device: Synchronized NIMV

During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute.

S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator.


S-NIMV followed by NIMV
During the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV.
Device: non-synchronized NIMV

During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute.

NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO).


Device: Synchronized NIMV

During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute.

S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator.





Primary Outcome Measures :
  1. Ventilation [ Time Frame: 4 hours ]
    Measurements of minute ventilation (VE) and tidal volume (VT) during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV


Secondary Outcome Measures :
  1. tidal volume [ Time Frame: 4 hours ]
    To compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT),

  2. Gas exchange [ Time Frame: 4 hours ]
    Measurements of arterial oxygen saturation, fraction of inspired oxygen, transcutaneous carbon dioxide obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV


Other Outcome Measures:
  1. Breathing effort [ Time Frame: 4 hours ]
    Measurements of inspiratory breathing effort obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  2. Chest wall distortion [ Time Frame: 4 hours ]
    Measurements of inspiratory chest wall distortion (phase lag and Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  3. apnea [ Time Frame: 4 hours ]
    Measurements of apneic respiratory pauses obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants of 30 or less weeks of gestational age
  • Receiving NIMV
  • Requiring Fi02 > 0.21 to keep Sp02 > 90%
  • Parental written informed consent

Exclusion Criteria:

  • Major congenital anomalies
  • Proven sepsis within 72 hours of the study
  • Hypotension requiring pressors within 72 hours of the study
  • Pneumothorax or pneumomediastinum within 72 hours of the study
  • Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085499


Contacts
Contact: Carmen D'Ugard, MD/RRT 3055856408 cdugard@med.miami.edu

Locations
United States, Florida
Holtz Childrens Hospital-Jackson Health System-University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Carmen D'Ugard, MD/RRT    305-585-6408    cdugard@med.miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Nelson Claure, MSc, PhD University of Miami
Principal Investigator: Eduardo Bancalari, MD University of Miami

Responsible Party: Nelson Claure, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02085499     History of Changes
Other Study ID Numbers: 20130844
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Nelson Claure, University of Miami:
nasal ventilation
premature infants
synchronized ventilation