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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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).
Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).
Department of Neonatology, University Hospital Zurich
Zurich, Switzerland
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
Time frame: 180-minute recording periods for each therapy
Paired difference in respiratory rate
Time frame: 180-minute recording periods for each therapy
Paired difference in heart rate
Time frame: 180-minute recording periods for each therapy
Paired difference in fraction of inspired oxygen [FiO2]
Time frame: 180-minute recording periods for each therapy
Paired difference in peripheral oxygen saturation [SpO2]
Time frame: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with oxygen saturations < 80%
Time frame: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with heart rates < 80 bpm
Time frame: 180-minute recording periods for each therapy
Paired difference in the number of apneas requiring stimulation
Time frame: 180-minute recording periods for each therapy
Paired difference in transcutaneous CO2 measurements
Time frame: 180-minute recording periods for each therapy
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.
Time frame: 180-minute recording periods for each therapy
Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.
EELI using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At the end of each intervention period
Paired difference in regional ventilation distribution in a subset of patients.
Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At the end of each intervention period
Paired difference in Tidal volumes in a subset of patients.
Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At the end of each intervention period
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.
Time frame: At the end of each intervention period
Paired difference in the rate of pneumothorax
Time frame: 180-minute recording periods for each therapy
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
Time frame: 180-minute recording periods for each therapy
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