Skip to main content
OpenTrials
Completed

NCT Number: NCT02085499

Flow-synchronized Nasal IMV in Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Infant Disease Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holtz Childrens Hospital-Jackson Health System-University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-synchronized NIMV

Other

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).

Synchronized NIMV

Other

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 outcomes

  1. Minute Ventilation

    Time frame: 4 hours

    Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

  2. Ttidal volume (VT)

    Time frame: 4 hours

    Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

Secondary outcomes

  1. Arterial oxygen saturation

    Time frame: 4 hours

    Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  2. fraction of inspired oxygen

    Time frame: 4 hours

    Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  3. transcutaneous carbon dioxide tension

    Time frame: 4 hours

    Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

Other outcomes

  1. Inspiratory breathing effort

    Time frame: 4 hours

    Measurements of inspiratory breathing effort obtained by esophageal manometry (cmH2O) during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  2. Chest wall distortion by Tcd/Vt ratio

    Time frame: 4 hours

    Measurements of inspiratory chest wall distortion (Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  3. Chest wall distortion by phase lag

    Time frame: 4 hours

    Measurements of inspiratory chest wall distortion (phase lag in degrees) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

  4. apnea frequency

    Time frame: 4 hours

    Measurements of apneic respiratory pauses (#/hour) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2014
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.