Dataset Information

Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea).

ABSTRACT:

Study objectives

To compare the treatment effect of noninvasive positive pressure ventilation (NPPV) and anticyclic servoventilation in patients with continuous positive airway pressure (CPAP)-induced central sleep apnea (complex sleep apnea).

Design

Randomized controlled trial.

Setting

Sleep center.

Patients

Thirty patients who developed complex sleep apnea syndrome (CompSAS) during CPAP treatment.

Interventions

NPPV or servoventilation.

Measurements and results

Patients were randomized to NPPV or servo-ventilation. Full polysomnography (PSG) was performed after 6 weeks. On CPAP prior to randomization, patients in the NPPV and servoventilator arm had comparable apnea-hypopnea indices (AHI, 28.6 ± 6.5 versus 27.7 ± 9.7 events/h (mean ± standard deviation [SD])), apnea indices (AI,19 ± 5.6 versus 21.1 ± 8.6 events/h), central apnea indices (CAI, 16.7 ± 5.4 versus 18.2 ± 7.1 events/h), oxygen desaturation indices (ODI,17.5 ± 13.1 versus 24.3 ± 11.9 events/h). During initial titration NPPV and servoventilation significantly improved the AHI (9.1 ± 4.3 versus 9 ± 6.4 events/h), AI (2 ± 3.1 versus 3.5 ± 4.5 events/h) CAI (2 ± 3.1 versus 2.5 ± 3.9 events/h) and ODI (10.1 ± 4.5 versus 8.9 ± 8.4 events/h) when compared to CPAP treatment (all P < 0.05). After 6 weeks we observed the following differences: AHI (16.5 ± 8 versus 7.4 ± 4.2 events/h, P = 0.027), AI (10.4 ± 5.9 versus 1.7 ± 1.9 events/h, P = 0.001), CAI (10.2 ± 5.1 versus 1.5 ± 1.7 events/h, P < 0.0001)) and ODI (21.1 ± 9.2 versus 4.8 ± 3.4 events/h, P < 0.0001) for NPPV and servoventilation, respectively. Other sleep parameters were unaffected by any form of treatment.

Conclusions

After 6 weeks, servoventilation treated respiratory events more effectively than NPPV in patients with complex sleep apnea syndrome.

SUBMITTER: Dellweg D

PROVIDER: S-EPMC3700713 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea).

Dellweg Dominic D Kerl Jens J Hoehn Ekkehard E Wenzel Markus M Koehler Dieter D

Sleep 20130801 8

<h4>Study objectives</h4>To compare the treatment effect of noninvasive positive pressure ventilation (NPPV) and anticyclic servoventilation in patients with continuous positive airway pressure (CPAP)-induced central sleep apnea (complex sleep apnea).<h4>Design</h4>Randomized controlled trial.<h4>Setting</h4>Sleep center.<h4>Patients</h4>Thirty patients who developed complex sleep apnea syndrome (CompSAS) during CPAP treatment.<h4>Interventions</h4>NPPV or servoventilation.<h4>Measurements and r ...[more]

PMID: 23904676

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Project description:BackgroundObstructive sleep apnea is associated with hypertension, inflammation, and increased cardiovascular risk. Continuous positive airway pressure (CPAP) reduces blood pressure, but adherence is often suboptimal, and the benefit beyond management of conventional risk factors is uncertain. Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea, we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk.MethodsWe conducted a randomized, controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices. Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire, and home sleep testing was used to establish the diagnosis. Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone (the control group) or, in addition to education, either CPAP or nocturnal supplemental oxygen. Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment. The primary outcome was 24-hour mean arterial pressure.ResultsOf 318 patients who underwent randomization, 281 (88%) could be evaluated for ambulatory blood pressure at both baseline and follow-up. On average, the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group (-2.4 mm Hg; 95% confidence interval [CI], -4.7 to -0.1; P=0.04) or the group receiving supplemental oxygen (-2.8 mm Hg; 95% CI, -5.1 to -0.5; P=0.02). There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen. A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis.ConclusionsIn patients with cardiovascular disease or multiple cardiovascular risk factors, the treatment of obstructive sleep apnea with CPAP, but not nocturnal supplemental oxygen, resulted in a significant reduction in blood pressure. (Funded by the National Heart, Lung, and Blood Institute and others; HeartBEAT ClinicalTrials.gov number, NCT01086800 .).

Project description:BackgroundVarious noninvasive respiratory support modalities are available in neonatal critical care in order to minimize invasive ventilation. Continuous positive airway pressure (CPAP) is the more commonly used but noninvasive positive pressure ventilation (NIPPV) seems more efficacious in the early post-extubation phase, although it is not clear if NIPPV may influence longterm outcomes. A recently introduced alternative is noninvasive high frequency oscillatory ventilation (NHFOV) which might be especially useful in babies needing high constant distending pressure. Preterm neonates may receive these respiratory supports for several weeks. Nonetheless, no data are available for the longterm use of NIPPV and NHFOV; few data exist on NHFOV and clinical outcomes, although its safety and suitability are reported in a number of preliminary short-term studies.MethodsWe designed an assessor-blinded, multicenter, three-arms, parallel, pragmatic, randomized, controlled trial with a superiority design, investigating the use of CPAP vs NIPPV vs NHFOV during the whole stay in neonatal intensive care units in China. Since safety data will also be analyzed it may be considered a phase II/III trial. Moreover, subgroup analyses will be performed on patients according to prespecified criteria based on physiopathology traits: these subgroup analyses should be considered preliminary. At least 1440 neonates are supposed to be enrolled. The trial has been designed with the collaboration of international colleagues expert in NHFOV, who will also perform an interim analysis at the about 50% of the enrolment.DiscussionThe study is applying the best trial methodology to neonatal ventilation, a field where it is often difficult to do so for practical reasons. Nonetheless, ours is also a physiology-driven trial, since interventions are applied based on physiological perspective, in order to use ventilatory techniques at their best. The pragmatic design will increase generalizability of our results but subgroup analyses according to predefined physiopathological criteria are also previewed trying to have some advantages of an explanatory design. Since not all clinicians are well versed in all respiratory techniques, the training is pivotal. We intend to apply particular care to train the participating units: a specific 3-month period and several means have been dedicated to this end.Trial registrationNCT03181958 (registered on June 9, 2017).

Dataset Information

Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea).

Study objectives

Design

Setting

Patients

Interventions

Measurements and results

Conclusions

Publications

Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea).

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