Flow-synchronized Nasal IMV in Preterm Infants

Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation 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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Premature Infant Disease
• Intervention / Treatment: Other: non-synchronized NIMV; Other: Synchronized NIMV

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Holtz Childrens Hospital-Jackson Health System-University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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).; Other: 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.
Other: 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.	Other: 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).; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute Ventilation	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	4 hours
Ttidal volume (VT)	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	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen saturation	Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours
fraction of inspired oxygen	Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours
transcutaneous carbon dioxide tension	Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory breathing effort	Measurements of inspiratory breathing effort obtained by esophageal manometry (cmH2O) during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours
Chest wall distortion by Tcd/Vt ratio	Measurements of inspiratory chest wall distortion (Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours
Chest wall distortion by phase lag	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 hours
apnea frequency	Measurements of apneic respiratory pauses (#/hour) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV	4 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Eduardo Bancalari, MD, University of Miami; Principal Investigator: Nelson Claure, MSc, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: nasal ventilation; premature infants; synchronized ventilation; non-invasive respiratory support
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Insufficiency
• Other Study ID Numbers: 20130844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No