Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants

Infant, Premature, Diseases Clinical Trial

— Osciflow  

Official title:

Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327466
• Other study ID #: High frequency highflow
• Status: Completed
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: January 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in premature infants. It uses a crossover design. Infants are randomized to begin the study with either Osciflow or HF. Both modes are applied for 4 hours. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate, and with a transcutaneous CO2-transducer. Further measurements include respiratory rate and 'Bernese pain scale' evaluated by nursing staff and Electrical Impedance Tomography (EIT) in a subset of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Preterm infants born with a gestational age of <35 weeks

• >72 hours old

• On nCPAP with PEEP 5 mbar and FiO2 <0.3

Exclusion Criteria:

• Severe congenital malformations adversely affecting life expectancy

Related Conditions & MeSH terms

• Apnea of Prematurity
• Bradycardia
• Infant, Premature, Diseases

Intervention

Device:
• Osciflow
Osciflow is a non-invasive high frequency oscillatory ventilation support delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).
• Highflow
Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Locations

Country	Name	City	State
Switzerland	Department of Neonatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Rub DM, Sivieri EM, Abbasi S, Eichenwald E. Effect of high-frequency oscillation on pressure delivered by high flow nasal cannula in a premature infant lung model. Pediatr Pulmonol. 2019 Nov;54(11):1860-1865. doi: 10.1002/ppul.24459. Epub 2019 Jul 24. — View Citation

Sivieri EM, Eichenwald E, Bakri SM, Abbasi S. Effect of high frequency oscillatory high flow nasal cannula on carbon dioxide clearance in a premature infant lung model: A bench study. Pediatr Pulmonol. 2019 Apr;54(4):436-443. doi: 10.1002/ppul.24216. Epub 2018 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired difference in the total number of desaturations and bradycardia between Osciflow and HF		180-minute recording periods for each therapy
Secondary	Paired difference in respiratory rate		180-minute recording periods for each therapy
Secondary	Paired difference in heart rate		180-minute recording periods for each therapy
Secondary	Paired difference in fraction of inspired oxygen [FiO2]		180-minute recording periods for each therapy
Secondary	Paired difference in peripheral oxygen saturation [SpO2]		180-minute recording periods for each therapy
Secondary	Paired difference in the proportion of time spent with oxygen saturations < 80%		180-minute recording periods for each therapy
Secondary	Paired difference in the proportion of time spent with heart rates < 80 bpm		180-minute recording periods for each therapy
Secondary	Paired difference in the number of apneas requiring stimulation		180-minute recording periods for each therapy
Secondary	Paired difference in transcutaneous CO2 measurements		180-minute recording periods for each therapy
Secondary	Paired difference in pain assessment using 'Bernese pain scale'	Bernese Pain-Scale for Neonates (BPSN): a 9-item multidimensional pain assessment tool that includes behavioral and physiological indicators. The instrument consists of seven subjective (alertness, crying, consolation, skin color, facial expression, posture, and changes in respiratory rate) and two physiological (i.e. objective) (changes in heart rate and oxygen saturation) indicators. Each item is rated on a four point Likert scale (0, 1, 2, and 3). Higher scores indicate greater pain-related distress, and a total score of 11 or higher is considered to indicate pain.	180-minute recording periods for each therapy
Secondary	Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.	EELI using electrical impedance tomography (arbitrary units per kilogram).	At the end of each intervention period
Secondary	Paired difference in regional ventilation distribution in a subset of patients.	Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).	At the end of each intervention period
Secondary	Paired difference in Tidal volumes in a subset of patients.	Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).	At the end of each intervention period
Secondary	Paired difference in nasal trauma score	Royal Women's Hospital Nasal Integrity and Pressure Chart.; Nasal injury is defined as stage 0-skin intact; stage 1-nonblanchable erythema of intact skin; stage 2-partial thickness skin loss involving epidermis, dermis, or both; stage 3-full thickness skin loss involving damage to or necrosis of subcutaneous tissue; stage 4-full thickness skin loss with extensive destruction, tissue necrosis, or damage to supporting structures.; Lowest Score: 0. Highest Score: 4. A higher score indicates more extensive nasal injury.	At the end of each intervention period
Secondary	Paired difference in the rate of pneumothorax		180-minute recording periods for each therapy
Secondary	Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:	Definition of failure criteria; Respiratory rate >90/min for more than 30 minutes; Respiratory rate >20/min higher than at the beginning of the study; Increase in FiO2 by = 0.25 from baseline for more than 30 minutes; Apnea-Score of more than 20/4 hours	180-minute recording periods for each therapy