Flow-synchronized Nasal IMV in Preterm Infants

NCT ID: NCT02085499

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

non-synchronized NIMV

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: OTHER

non-synchronized NIMV

Intervention Type: 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

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Nelson Claure

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelson Claure, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Eduardo Bancalari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Holtz Childrens Hospital-Jackson Health System-University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20130844

Identifier Type: -

Identifier Source: org_study_id