Respiratory adverse events associated with deep propofol sedation during upper gastrointestinal procedures in children

Background/Aims: Upper airway stimulation with endoscopes and pH-impedance probes during deep propofol sedation confers unknown risk for associated respiratory adverse airway events. This report quantifies frequencies of such events and airway rescue interventions associated with Esophagogastroduodenoscopies (EGD) and multi-channel intraluminal acid detection impedance probe (MIIP) placements. Methods: This was a prospective observational study regarding occurrence of adverse respiratory events in 42 children undergoing propofol sedated EGDs and MIIP placements: Group 1. (n=21 EGDs), Group2 (n=21 EGDs before MIIP), Group 3. (n=21 during MIIP). Results: All procedures were successfully completed using deep propofol sedation. Respiratory events were transient and associated with no morbidity or mortality. Nearly half of each group experienced a respiratory event. “Partial airway obstruction” during 42 EGDs occurred in 28.6% and responded to simple airway interventions. “Complete airway obstruction” occurred during 1/42 EGDs and 2/21 MIIPs. Throughout MIIP placement, endoscopic visualization of the glottis was maintained and unnecessary stimulation of the glottis was avoided; nonetheless, complete airway obstruction occurred in 2/21. Advanced airway rescue maneuvers were not required in either instance. Conclusions: Respiratory adverse events commonly occurred during EGDs and MIIP placements. All events were successfully rescued by simple airway interventions.

Post-operative Complication Rate Comparison Between Airway Surgery and Upper Airway Stimulation Using NSQIP and ADHERE

Objective Postoperative complication rates were compared between obstructive sleep apnea surgery (OSAS) and hypoglossal nerve upper airway stimulation (UAS). Study Design Cohort. Setting Multi-institutional international databases. Methods OSAS data were collected from the NSQIP database (2014; American College of Surgeons National Surgery Quality Improvement Program). UAS data were obtained from the ADHERE registry (Adherence and Outcome of Upper Airway Stimulation for OSA International Registry; 2016–December 2019). ADHERE comorbidities and complications were categorized to match NSQIP definitions. A chi-square test was used for proportion P values. Results There were 1623 UAS procedures in ADHERE and 310 in NSQIP. The UAS group was older than the OSAS group (mean ± SD, 60 ± 11 vs 42 ± 13 years) but similarly male (75% vs 77%) and overweight (body mass index, 29 ± 4 vs 29 ± 3 kg/m2). There was a higher proportion of hypertension, diabetes, and heart disease in the UAS cohort. Palatopharyngoplasty was the most common surgical procedure (71%), followed by tonsillectomy (25%). UAS operative time was longer (132 ± 47 vs 54 ± 33 minutes). Postoperative length of stay was not normally distributed, as 71% of UAS stays were <1 day as opposed to 40% of OSA stays ( P < .0001). Thirty-day return to the operating room related to the procedure was 0.1% for UAS and 4.8% for OSAS ( P < .0001). Surgical site infections were 0.13% for UAS and 0.9% for OSAS ( P = .046). Conclusion The UAS cohort was older and more likely to have comorbid hypertension, diabetes, and heart disease. Despite baseline differences, the postoperative complication rate was lower with UAS than with OSAS.

Effect of Upper Airway Stimulation in Patients with Obstructive Sleep Apnea (EFFECT): A Randomized Controlled Crossover Trial

Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

433 Insomnia and Restless Legs Syndrome in Patients with Upper Airway Stimulation Therapy

Introduction Insomnia and restless legs syndrome (RLS) are common sleep disorders that may impact obstructive sleep apnea (OSA) treatment. To our knowledge, no studies have investigated whether these comorbidities affect upper airway stimulation (UAS) therapy adherence and outcomes. This study aims to explore possible effects of insomnia and RLS in patients using UAS therapy. Methods All patients who underwent UAS system implantation for treatment of OSA at our facility were retrospectively studied. Pre- and post-implant histories and data, including diagnostic sleep testing, otolaryngology evaluation, activation results, and treatment evaluation, were analyzed. Patients with no insomnia or RLS were compared to patients with insomnia, RLS, or both. Apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and adherence were compared pre- and post-treatment for each group. Results Sixty-four patients who have undergone UAS implantation at our center have completed post-treatment in-lab titration and evaluation of their UAS system. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. In all groups, the overall AHI during in-lab titration was &gt;50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p&lt;0.001). While the trend in AHI reductions suggested a lower AHI in those without insomnia or RLS, the reduction did not reach statistical significance (no insomnia or RLS 15.7+/-12.9/h, insomnia 16.9+/-16.7/h, RLS 19.0+/-15.5/h, both insomnia and RLS 23.4+/-18.4/h). UAS therapy usage was reduced in patients with RLS (3.9+/-2.6 h/night, p=0.029) and in patients with both insomnia and RLS (3.9+/-1.3 h/night, p=0.046) compared to patients with neither comorbidity (5.9+/-1.9 h/night). Mean reduction in ESS was similar across groups, averaging from 11+/-5 pre-treatment to 7+/-5 post-treatment (p&lt;0.001). Conclusion Insomnia and RLS are common in patients using UAS therapy for OSA. Pre- and post-treatment residual AHI and ESS significantly improved in all patient groups assessed. A decrease in UAS usage was present in patients with RLS and both RLS and insomnia. Our study suggests that identification and treatment of RLS and insomnia may play an important role for UAS therapy adherence and efficacy, thus, optimizing care. Support (if any):