Colm P Travers1, Waldemar A Carlo2, Arie Nakhmani3, Shweta Bhatia4, Samuel J Gentle2, VenkataNagaSai Apurupa Amperayani5, Premananda Indic5, Inmaculada Aban6, Namasivayam Ambalavanan2. 1. Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL. Electronic address: ctravers@peds.uab.edu. 2. Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL. 3. Department of Electrical and Computer Engineering, University of Alabama at Birmingham, Birmingham, AL. 4. University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC. 5. Department of Electrical Engineering, University of Texas at Tyler, Tyler, TX. 6. Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.
Abstract
OBJECTIVE: To test the hypothesis that environmental compared with nasal cannula oxygen decreases episodes of intermittent hypoxemia (oxygen saturations <85% for ≥10 seconds) in preterm infants on supplemental oxygen by providing a more stable hypopharyngeal oxygen concentration. STUDY DESIGN: This was a single center randomized crossover trial with a 1:1 parallel allocation to order of testing. Preterm infants onsupplemental oxygen via oxygen environment maintained by a servo-controlled system or nasal cannula with flow rates ≤1.0 L per kg per minute were crossed over every 24 hours for 96 hours. Data were collected electronically to capture real time numeric and waveform data from patient monitors. RESULTS:Twenty-five infants with gestational age of 27 ± 2 weeks (mean ± SD) and a birth weight of 933 ± 328 g were studied at postnatal day 36 ± 26. The number of episodes of intermittent hypoxemia per 24 hours was 117 ± 77 (median, 98; range, 4-335) with oxygen environment vs 130 ± 63 (median, 136; range, 16-252) with nasal cannula (P = .002). Infants on oxygen environment compared with nasal cannula also had decreased episodes of severe intermittent hypoxemia (P = .005). Infants on oxygen environment compared with nasal cannula had a lower proportion of time with oxygen saturations <85% (.05 ± .03 vs .06 ± .03, P < .001), and a lower coefficient of variation of oxygen saturation (P = .02). CONCLUSIONS: In preterm infants receivingsupplemental oxygen, servo-controlled oxygen environment decreases hypoxemia compared with nasal cannula. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02794662.
RCT Entities:
OBJECTIVE: To test the hypothesis that environmental compared with nasal cannula oxygen decreases episodes of intermittent hypoxemia (oxygen saturations <85% for ≥10 seconds) in preterm infants on supplemental oxygen by providing a more stable hypopharyngeal oxygen concentration. STUDY DESIGN: This was a single center randomized crossover trial with a 1:1 parallel allocation to order of testing. Preterm infants on supplemental oxygen via oxygen environment maintained by a servo-controlled system or nasal cannula with flow rates ≤1.0 L per kg per minute were crossed over every 24 hours for 96 hours. Data were collected electronically to capture real time numeric and waveform data from patient monitors. RESULTS: Twenty-five infants with gestational age of 27 ± 2 weeks (mean ± SD) and a birth weight of 933 ± 328 g were studied at postnatal day 36 ± 26. The number of episodes of intermittent hypoxemia per 24 hours was 117 ± 77 (median, 98; range, 4-335) with oxygen environment vs 130 ± 63 (median, 136; range, 16-252) with nasal cannula (P = .002). Infants on oxygen environment compared with nasal cannula also had decreased episodes of severe intermittent hypoxemia (P = .005). Infants on oxygen environment compared with nasal cannula had a lower proportion of time with oxygen saturations <85% (.05 ± .03 vs .06 ± .03, P < .001), and a lower coefficient of variation of oxygen saturation (P = .02). CONCLUSIONS: In preterm infants receiving supplemental oxygen, servo-controlled oxygen environment decreases hypoxemia compared with nasal cannula. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02794662.
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