Dataset Information

The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial.

ABSTRACT:

Background

Obstructive sleep apnea (OSA) is associated with neurocognitive impairment - a known risk factor for postoperative delirium. However, it is unclear whether OSA increases the risk of postoperative delirium and whether treatment is protective. The objectives of this study were to identify OSA with a home sleep apnea test (HSAT) and to determine whether auto-titrating positive airway pressure (APAP) reduces postoperative delirium in older adults with newly diagnosed OSA undergoing elective hip or knee arthroplasty.

Methods

We conducted a multi-centre, randomized controlled trial at three academic hospitals in Canada. Research ethics board approval was obtained from the participating sites and informed consent was obtained from participants. Inclusion criteria were patients who were [Formula: see text]0 years and scheduled for elective hip or knee replacement. Patients with a STOP-Bang score of ≥ 3 had a HSAT. Patients were defined as having OSA if the apnea-hypopnea index was ≥ 10/h. These patients were randomized 1:1 to either: 1) APAP for 72 h postoperatively or until discharge, or 2) routine care after surgery. The primary outcome was postoperative delirium, assessed twice daily with the Confusion Assessment Method for 72 h or until discharge or by chart review. The secondary outcome measures included length of stay, and perioperative complications occurring within 30 days after surgery.

Results

Of 549 recruited patients, 474 completed a HSAT. A total of 234 patients with newly diagnosed OSA were randomized. The mean age was 68.2 (6.2) years and 58.6% were male. Analysis was performed on 220 patients. In total, 2.7% (6/220) patients developed delirium after surgery: 4.4% (5/114) patients in the routine care group, and 0.9% (1/106) patients in the treatment group (P = 0.21). The mean length of stay for the APAP vs. the routine care group was 2.9 (2.9) days vs. 3.5 (4.5) days (P = 0.24). On postoperative night 1, 53.5% of patients used APAP for 4 h/night or more, this decreased to 43.5% on night 2, and 24.6% on night 3. There was no difference in intraoperative and postoperative complications between the two groups.

Conclusions

We had an unexpectedly low rate of postoperative delirium thus we were unable to determine if postoperative delirium was reduced in older adults with newly diagnosed OSA receiving APAP vs. those who did not receive APAP after elective knee or hip arthroplasty.

Trial registration

This trial was retrospectively registered in clinicaltrials.gov NCT02954224 on 03/11/2016.

SUBMITTER: Wong J

PROVIDER: S-EPMC9472354 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial.

Wong Jean J Doherty Helen R HR Singh Mandeep M Choi Stephen S Siddiqui Naveed N Lam David D Liyanage Nishanthi N Tomlinson George G Chung Frances F

BMC anesthesiology 20220914 1

<h4>Background</h4>Obstructive sleep apnea (OSA) is associated with neurocognitive impairment - a known risk factor for postoperative delirium. However, it is unclear whether OSA increases the risk of postoperative delirium and whether treatment is protective. The objectives of this study were to identify OSA with a home sleep apnea test (HSAT) and to determine whether auto-titrating positive airway pressure (APAP) reduces postoperative delirium in older adults with newly diagnosed OSA undergoin ...[more]

PMID: 36104664

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Project description:BackgroundDelirium is a common problem that occurs in 5-50% of elderly individuals following surgery. Patients who develop delirium after surgery are at increased risk for serious complications. Recent studies suggest that patients with obstructive sleep apnea (OSA), a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. OSA is more common in elderly individuals but is often undiagnosed. Identification and treatment of unrecognized OSA may reduce the incidence of postoperative delirium. However, few studies have investigated the effect of perioperative treatment of OSA to prevent postoperative delirium.MethodsThis multi-centre randomized controlled trial will enrol 634 elderly patients undergoing elective hip/knee replacement surgery. The study has been approved by the Research Ethics Boards of the three participating institutions. Patients will be screened with the STOP-Bang questionnaire. Those with a score of 3 or greater will have a portable home sleep study using the ApneaLink™ Air device. Patients identified to have OSA will be randomized to 1) Auto-titrating continuous positive airway pressure (APAP) applied during sleep for 72 h after surgery or until discharge if they are discharged before 72 h or 2) Control group - routine care, no APAP. All patients will be evaluated for delirium for 72 h after surgery or until discharge if they are discharged before 72 h. The primary outcome is the occurrence of delirium - assessed twice daily using the Confusion Assessment Method for 72 h or until discharge if the hospital stay is <72 h.DiscussionDelirium is associated with increased morbidity and mortality, and higher healthcare costs. With the aging population, the incidence of postoperative delirium will likely increase as the number of elderly individuals undergoing surgery rises. The results of our study will be published in a peer-reviewed journal and presented at local and international medical conferences. Our study findings may lead to improved surgical outcomes, enhanced patient safety and reduced healthcare costs.Trial registrationThis study was retrospectively registered at clinicaltrials.gov NCT02954224 on November 3, 2016.

Project description:Rationale: Primary treatment of obstructive sleep apnea can be accompanied by a persistence of excessive sleepiness despite adherence. Furthermore, effectiveness of sleep apnea treatment is limited by poor adherence. Currently available pharmacologic options for the treatment of sleepiness in this population are limited. Objectives: To evaluate the efficacy and safety of solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, for the treatment of excessive sleepiness in participants with obstructive sleep apnea with current or prior sleep apnea treatment. Methods: This was a double-blind, randomized, placebo-controlled, parallel-group, 12-week trial comparing solriamfetol, 37.5, 75, 150, and 300 mg, with placebo. Measurements and Main Results: Of 476 randomized participants, 459 were included in the prespecified efficacy analyses. Coprimary endpoints (Maintenance of Wakefulness Test sleep latency and Epworth Sleepiness Scale score) were met at all solriamfetol doses (P < 0.05), with dose-dependent effects observed at Week 1 maintained over the study duration. All doses except 37.5 mg resulted in higher percentages of participants reporting improvement on Patient Global Impression of Change (key secondary endpoint; P < 0.05). Adverse events were reported in 47.9% of placebo- and 67.9% of solriamfetol-treated participants; five participants experienced serious adverse events (two [1.7%] placebo, three [0.8%] solriamfetol); none were deemed related to study drug. The most common adverse events with solriamfetol were headache (10.1%), nausea (7.9%), decreased appetite (7.6%), anxiety (7.0%), and nasopharyngitis (5.1%). Conclusions: Solriamfetol significantly increased wakefulness and reduced sleepiness in participants with obstructive sleep apnea and excessive sleepiness; most adverse events were mild or moderate in severity. Clinical trial registered with www.clinicaltrials.gov (NCT02348606) and www.eudract.ema.europa.eu (EudraCT 2014-005514-31).

Project description:BackgroundObstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA.MethodsA multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence.ResultsOf 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21).ConclusionsCPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.

Project description:BackgroundMyofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises.ObjectiveWe conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS.MethodsForty patients with severe OSAHS (apnea-hypoxia index [AHI]>30) were enrolled prospectively and randomized into an intervention group that used the app for 90 sessions or a control group. Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were measured before and after the intervention.ResultsAfter the intervention, 28 patients remained. No significant changes were observed in the control group; however, the intervention group showed significant improvements in most metrics. AHI decreased by 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/hour (P<.001). The oxygen desaturation index decreased by 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/hour (P=.003). The IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001), and the IOPI maximum lip score increased from 27.89 (24.16-32.47) to 44.11 (39.5-48.8) kPa (P<.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson correlation coefficient -0.56 and -0.46, respectively; both P<.001). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) in the app group (P<.001), but the Pittsburgh Sleep Quality Index did not change significantly.ConclusionsOrofacial exercises performed using an mHealth app reduced OSAHS severity and symptoms, and represent a promising treatment for OSAHS.Trial registrationSpanish Registry of Clinical Studies AWGAPN-2019-01, ClinicalTrials.gov NCT04438785; https://clinicaltrials.gov/ct2/show/NCT04438785.

Project description:BackgroundObstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy.ObjectiveThis study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters.MethodsThis randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization's tool to measure QoL (WHOQOL-BREF) score; and lipid profile values.ResultsStudy recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone.ConclusionsThe study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA.Trial registrationClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456.International registered report identifier (irrid)DERR1-10.2196/47460.

Dataset Information

The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial.

Similar Datasets

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