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

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

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

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.

Non-invasive respiratory support, Non-invasive high frequency oscillatory ventilation, Highflow nasal cannula

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).

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.

Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).

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.

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

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

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.

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.