Haley Fishman1,2, Colin Massicotte1, Rhonda Li1, Weeda Zabih1,2, Laura C McAdam1,2,3, Suhail Al-Saleh1,2, Reshma Amin1,2. 1. Division of Respiratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada. 2. University of Toronto, Toronto, Ontario, Canada. 3. Division of Developmental Pediatrics, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.
Abstract
STUDY OBJECTIVES:Polysomnography (PSG) surveillance recommendations are not being met for children with neuromuscular disease (NMD) because of limited diagnostic facilities. We evaluated the diagnostic accuracy of an ambulatory level III device as compared to a level I PSG. METHODS: A cross-sectional study was conducted at a tertiary pediatric institution. Eligibility criteria included: (1) children with NMD; (2) age 6 to 18 years; (3) booked for a clinically indicated overnight level I PSG. Participants were randomized to an overnight level I PSG followed by an ambulatory level III study with end tidal carbon dioxide (etCO2) or vice versa. Sensitivity and specificity of the ambulatory level III device to diagnose sleep-disordered breathing (SDB) at an apnea-hypopnea index (AHI) cutoff of >; 1.0 events/h was the primary outcome. RESULTS:Moderate to severe SDB was found in 46% of participants (13/28). The device's sensitivity and specificity to detect SDB was 61.5% and 86.7%, respectively. The positive predictive value of the level III study was 80.0% and the negative predictive value was 72.0%. Fifty percent of the cohort were either missing or had incomplete or falsely low ambulatory etCO2 data. CONCLUSIONS: A level III device with etCO2 is not yet able to be implemented in clinical practice as a diagnostic tool for SDB in pediatric patients with NMD. COMMENTARY: A commentary on this article appears in this issue on page 1973.
RCT Entities:
STUDY OBJECTIVES: Polysomnography (PSG) surveillance recommendations are not being met for children with neuromuscular disease (NMD) because of limited diagnostic facilities. We evaluated the diagnostic accuracy of an ambulatory level III device as compared to a level I PSG. METHODS: A cross-sectional study was conducted at a tertiary pediatric institution. Eligibility criteria included: (1) children with NMD; (2) age 6 to 18 years; (3) booked for a clinically indicated overnight level I PSG. Participants were randomized to an overnight level I PSG followed by an ambulatory level III study with end tidal carbon dioxide (etCO2) or vice versa. Sensitivity and specificity of the ambulatory level III device to diagnose sleep-disordered breathing (SDB) at an apnea-hypopnea index (AHI) cutoff of > 1.0 events/h was the primary outcome. RESULTS: Moderate to severe SDB was found in 46% of participants (13/28). The device's sensitivity and specificity to detect SDB was 61.5% and 86.7%, respectively. The positive predictive value of the level III study was 80.0% and the negative predictive value was 72.0%. Fifty percent of the cohort were either missing or had incomplete or falsely low ambulatory etCO2 data. CONCLUSIONS: A level III device with etCO2 is not yet able to be implemented in clinical practice as a diagnostic tool for SDB in pediatric patients with NMD. COMMENTARY: A commentary on this article appears in this issue on page 1973.
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