Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-19

Study Completion Date

2023-01-13

Brief Summary

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Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. Low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. Therefore, the aim of this study is to assess the effect of different HighFlow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.

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Detailed Description

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Conditions

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Infant, Premature, Diseases Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High Flow

Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data lung volume changes will be measured using electrical impedance tomography.

Group Type OTHER

High Flow

Intervention Type DEVICE

Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data on lung volume changes will be measured using electrical impedance tomography.

Interventions

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High Flow

Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data on lung volume changes will be measured using electrical impedance tomography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent by one or both parents or legal guardians as documented by signature
* 30 - 35 weeks postmenstrual age
* Respiratory support with nCPAP PEEP 5mbar and FiO2 \< 0.30
* \> 72 hours old

Exclusion Criteria

* Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
* Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)

Minimum Eligible Age

73 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No