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

NCT05237622 | Completed

• 1 other identifier: FunkFlow
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant, Premature, Diseases; Respiratory Distress Syndrome

Keywords

Non-invasive respiratory support; HighFlow; continuous positive airway pressure; functional residual capacity

Outcome Measures

Primary Outcomes (1)

• Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  Change in global EELI over time using electrical impedance tomography (EIT)

  230-minute recording period per patient, 30 minutes on each HF level

Secondary Outcomes (11)

• Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  230-minute recording period per patient, 30 minutes on each HF level

• Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  230-minute recording period per patient, 30 minutes on each HF level

• Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  230-minute recording period per patient, 30 minutes on each HF level

• Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  230-minute recording period per patient, 30 minutes on each HF level

• Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

  230-minute recording period per patient, 30 minutes on each HF level

Study Arms (1)

High Flow

OTHER

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.

Device: High Flow

Interventions

High Flow 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.

High Flow

Eligibility Criteria

• Age: 73 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Newborn Research, Department of Neonatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (3)

• Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.

  PMID: 23260098 BACKGROUND

• Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

  PMID: 27596161 BACKGROUND

• van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.

  PMID: 24561568 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: February 19, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CH (1)