Snorri Donaldsson1,2, Thomas Drevhammar2,3, Leena Taittonen4, Stina Klemming1, Baldvin Jonsson1,2. 1. Department of Neonatology, Karolinska University Hospital, Stockholm, Sweden. 2. Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. 3. Department of Anaesthesiology and ICU, Östersund Hospital, Östersund, Sweden. 4. Department of Paediatrics, Vaasa Central Hospital, Vaasa, Finland.
Abstract
OBJECTIVE: T-piece resuscitation systems are pressure unstable and have high imposed work of breathing (iWOB). Pressure stable respiratory support with low iWOB might improve outcome. We have developed a new resuscitation system that can be used with nasal prongs or face mask. The aim of the study was to describe the in vitro performance of the new system and to perform a clinical feasibility trial of initial stabilisation of preterm infants. METHOD: A mechanical lung model was used to determine iWOB at increasing levels of continuous positive airway pressure (CPAP). The feasibility trial included 36 infants (27-34 weeks of gestation), who were randomised into three groups (T-piece, new system with face mask or new system with prongs). Collected data included problems with usage, safety, time to stable breathing, need for positive pressure ventilation and intubation. RESULTS: In the mechanical lung model, the new system reduced iWOB with 91.5% (mask) and 86.6% (medium prongs) compared with Neopuff (4 cm CPAP, p<0.001). Informed consent was obtained from 45 patients, 39 were randomised and 36 needed support. Randomisation resulted in an imbalance: The group of new system infants had lower gestational age compared with the T-piece group. Thirteen patients needed positive pressure ventilation (median 20 cm H2O). One infant was intubated. The study did not reveal problems with the equipment or safety. CONCLUSIONS: Compared with T-piece systems, the new system had a marked reduction in iWOB in bench tests. The feasibility trial did not reveal problems with usability or safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
OBJECTIVE:T-piece resuscitation systems are pressure unstable and have high imposed work of breathing (iWOB). Pressure stable respiratory support with low iWOB might improve outcome. We have developed a new resuscitation system that can be used with nasal prongs or face mask. The aim of the study was to describe the in vitro performance of the new system and to perform a clinical feasibility trial of initial stabilisation of preterm infants. METHOD: A mechanical lung model was used to determine iWOB at increasing levels of continuous positive airway pressure (CPAP). The feasibility trial included 36 infants (27-34 weeks of gestation), who were randomised into three groups (T-piece, new system with face mask or new system with prongs). Collected data included problems with usage, safety, time to stable breathing, need for positive pressure ventilation and intubation. RESULTS: In the mechanical lung model, the new system reduced iWOB with 91.5% (mask) and 86.6% (medium prongs) compared with Neopuff (4 cm CPAP, p<0.001). Informed consent was obtained from 45 patients, 39 were randomised and 36 needed support. Randomisation resulted in an imbalance: The group of new system infants had lower gestational age compared with the T-piece group. Thirteen patients needed positive pressure ventilation (median 20 cm H2O). One infant was intubated. The study did not reveal problems with the equipment or safety. CONCLUSIONS: Compared with T-piece systems, the new system had a marked reduction in iWOB in bench tests. The feasibility trial did not reveal problems with usability or safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Kristel L A M Kuypers; Lieve A Willemsen; Sophie J E Cramer; Aidan J Kashyap; Thomas Drevhammar; Stuart B Hooper; Arjan B Te Pas Journal: Front Pediatr Date: 2022-03-17 Impact factor: 3.418