Flow-synchronized Nasal IMV in Preterm Infants

NCT02085499 | Completed

• 1 other identifier: 20130844
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant Disease; Respiratory Insufficiency

Keywords

nasal ventilation; premature infants; synchronized ventilation; non-invasive respiratory support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Arterial oxygen saturation

  4 hours

• fraction of inspired oxygen

  4 hours

• transcutaneous carbon dioxide tension

  4 hours

Other Outcomes (4)

• Inspiratory breathing effort

  4 hours

• Chest wall distortion by Tcd/Vt ratio

  4 hours

• Chest wall distortion by phase lag

  4 hours

Study Arms (2)

NIMV followed by S-NIMV

OTHER

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; Other: Synchronized NIMV

S-NIMV followed by NIMV

OTHER

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; Other: Synchronized NIMV

Interventions

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).

NIMV followed by S-NIMV; S-NIMV followed by NIMV

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.

NIMV followed by S-NIMV; S-NIMV followed by NIMV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Holtz Childrens Hospital-Jackson Health System-University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nelson Claure, MSc, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Eduardo Bancalari, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)