scholarly journals Through-and-Through Dissection of the Soft Palate for Pharyngeal Flap Inset: A “Good-Fast-Cheap” Technique for Any Etiology of Velopharyngeal Incompetence

2021 ◽  
pp. 105566562110217
Author(s):  
Michael Carr ◽  
Michaela Skarlicki ◽  
Sheryl Palm ◽  
Marija Bucevska ◽  
Jeffrey Bone ◽  
...  
Keyword(s):  
Soft Palate ◽  
Operative Time ◽  
Care Center ◽  
Tertiary Care ◽  
Deletion Syndrome ◽  
Complication Rates ◽  
Short Operative Time ◽  
Velopharyngeal Incompetence ◽  
Obstructive Sleep ◽  
Pharyngeal Flap

Objective: To determine the efficacy and resource utilization of through-and-through dissection of the soft palate for pharyngeal flap inset for velopharyngeal incompetence (VPI) of any indication. Design: Retrospective review. Setting: Tertiary care center. Patients: Thirty patients were included. Inclusion criteria were diagnosis of severe VPI based on perceptual speech assessment, confirmed by nasoendoscopy or videofluoroscopy; VPI managed surgically with modified pharyngeal flap with through-and-through dissection of the soft palate; and minimum 6 months follow-up. Patients with 22q11.2 deletion syndrome were excluded. Intervention: Modified pharyngeal flap with through-and-through dissection of the soft palate. Main Outcome Measure(s): Velopharyngeal competence and speech assessed using the Speech-Language Pathologist 3 scale. Results: The median preoperative speech score was 11 of 13 (range, 7 to 13), which improved significantly to a median postoperative score of 1 of 13 (range 0-7; P < .001). Velopharyngeal competence was restored in 25 (83%) patients, borderline competence in 3 (10%), and VPI persisted in 2 (7%) patients. Complications included 1 palatal fistula that required elective revision and 1 mild obstructive sleep apnea that did not require flap takedown. Median skin-to-skin operative time was 73.5 minutes, and median length of stay (LOS) was 50.3 hours. Conclusions: This technique allows direct visualization of flap placement and largely restores velopharyngeal competence irrespective of VPI etiology, with low complication rates. Short operative time and LOS extend the value proposition, making this technique not only efficacious but also a resource-efficient option for surgical management of severe VPI.

Defining Risk of Postoperative Obstructive Sleep Apnea in Patients With 22q11.2DS Undergoing Pharyngeal Flap Surgery for Velopharyngeal Dysfunction Using Polysomnographic Evaluation

2020 ◽  
Vol 57 (7) ◽  
pp. 808-818
Author(s):  
Alfred Lee ◽  
Brian L. Chang ◽  
Cynthia Solot ◽  
Terrence B. Crowley ◽  
Vamsee Vemulapalli ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Tertiary Care ◽  
22Q11.2 Deletion Syndrome ◽  
Deletion Syndrome ◽  
Apnea Hypopnea Index ◽  
Pressure Therapy ◽  
Obstructive Sleep ◽  
Increased Risk ◽  
Pharyngeal Flap

Objective: To determine pre- and postoperative prevalence of obstructive sleep apnea (OSA) in patients with 22q11.2 deletion syndrome (DS) undergoing wide posterior pharyngeal flap (PPF) surgery for velopharyngeal dysfunction (VPD). Design: Retrospective study using pre- and postoperative polysomnography (PSG) to determine prevalence of OSA. Medical records were reviewed for patients’ medical comorbidities. Parents were surveyed about snoring. Setting: Academic tertiary care pediatric hospital. Patients: Forty patients with laboratory confirmed 22q11.2DS followed over a 6-year period. Interventions: Pre- and postoperative PSG, speech evaluation, and parent surveys. Main Outcome Measure: Severity and prevalence of OSA, defined by obstructive apnea hypopnea index (OAHI), before and after PPF surgery to determine whether PPF is associated with increased risk of OSA. Results: Mean OAHI did not change significantly after PPF surgery (1.1/h vs 2.1/h, P = .330). Prevalence of clinically significant OSA (OAHI ≥ 5) was identical pre- and postoperatively (2 of 40), with both cases having severe-range OSA requiring positive airway pressure therapy. All other patients had mild-range OSA. Nasal resonance was graded as severe preoperatively in 85% of patients. None were graded as severe postoperatively. No single patient factor or parent-reported concern predicted risk of OSA (OAHI ≥ 1.5). Conclusions: Patients with 22q11.2DS are medically complex and are at increased risk of OSA at baseline. Wide PPF surgery for severe VPD does not significantly increase risk of OSA. Careful perioperative planning is essential to optimize both speech and sleep outcomes.

scholarly journals Polysomnographic Outcomes After Observation for Mild Obstructive Sleep Apnea in Children Younger Than 3 Years

2020 ◽  
pp. 019459982095438
Author(s):  
Kathleen M. Sarber ◽  
Douglas C. von Allmen ◽  
Raisa Tikhtman ◽  
Javier Howard ◽  
Narong Simakajornboon ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Care Center ◽  
Tertiary Care ◽  
Apnea Hypopnea Index ◽  
Optimal Timing ◽  
Obstructive Apnea ◽  
Obstructive Sleep ◽  
Mild Obstructive Sleep Apnea ◽  
The Impact

Objective Mild obstructive sleep apnea (OSA), particularly in young children, is often treated with observation. However, there is little evidence regarding the outcomes with this approach. Our aim was to assess the impact of observation on sleep for children aged <3 years with mild OSA. Study Design Case-control study. Setting Pediatric tertiary care center. Methods We reviewed cases of children (<3 years old) diagnosed with mild OSA (obstructive apnea-hypopnea index, 1-5 events/h) who were treated with observation between 2012 and 2017 and had at least 2 polysomnograms performed 3 to 12 months apart. Demographic data and comorbid diagnoses were collected. Results Twenty-six children met inclusion criteria; their median age was 7.2 months (95% CI, 1.2-22.8). Nine (35%) were female and 24 (92%) were White. Their median body mass index percentile was 39 (95% CI, 1-76). Comorbidities included cardiac disease (42.3%), laryngomalacia (42.3%), allergies (34.6%), reactive airway disease (23.1%), and prematurity (7.7%). The obstructive apnea-hypopnea index significantly decreased from 2.7 events/h (95% CI, 1-4.5) to 1.3 (95% CI, 0-4.5; P = .013). There was no significant improvement in median saturation nadir (baseline, 86%; P = .76) or median time with end-tidal carbon dioxide >50 mm Hg (baseline, 0 minutes; P = .34). OSA resolved in 8 patients (31%) and worsened in 1 (3.8%). Only race was a significant predictor of resolution per regression analysis; however, only 2 non-White children were included. Conclusion In our cohort, resolution of mild OSA occurred in 31% of patients treated with 3 to 12 months of observation. The presence of laryngomalacia, asthma, and allergies did not affect resolution. Larger studies are needed to better identify factors (including race) associated with persistent OSA and optimal timing of intervention for these children. Level of Evidence 4.

Timing of robotic hysterectomy after cervical excisional procedure

2019 ◽  
Vol 29 (7) ◽  
pp. 1110-1115
Author(s):  
Anna K. Melnikoff ◽  
David W. Doo ◽  
Alexander C. Cohen ◽  
Emily Landers ◽  
Christen Walters-Haygood ◽  
...  
Keyword(s):  
Surgical Intervention ◽  
Care Center ◽  
Tertiary Care ◽  
Complication Rates ◽  
Robotic Hysterectomy ◽  
Operative Complication ◽  
Operative Outcomes ◽  
Gynecology And Obstetrics ◽  
Estimated Blood Loss ◽  
Early Surgical Intervention

IntroductionWhile traditional teaching has been to wait 6 weeks between cervical excisional procedure and hysterectomy, studies have produced conflicting evidence, with data supporting a delay of anywhere between 48 hours to 6 weeks depending on surgical approach. Our study sought to evaluate if the time between cervical excisional procedure and robotic hysterectomy impacts peri-operative complication rates.MethodsA retrospective cohort of patients who underwent robotic hysterectomy from August 2006 to December 2013 for cervical dysplasia or International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA1–B1 cervical cancer at a single tertiary care center was performed. Patients were categorized into three groups: early surgical intervention (<6 weeks from excisional procedure), delayed surgical intervention (≥6 weeks from excisional procedure), and no excisional procedure. Secondary analysis was performed by hysterectomy type (simple vs radical). Peri-operative outcomes and complications were compared. Statistical analysis included Chi-square, Fisher’s exact test, and Wilcoxon rank sum test.ResultsA total of 160 patients were identified. Of these, 32 (20.0%) had early surgical intervention, 52 (32.5%) had delayed surgical intervention, and 76 (47.5%) had no excisional procedure. There was no difference between groups in complication rates, including average estimated blood loss (82 vs 55 vs 71 mL; p=0.07), urologic injury (0% in all groups; p=1.0), anemia (3% vs 0% vs 1%; p=0.47), infection (0% vs 2% vs 3%; p=1.0), vaginal cuff separation (0% in all groups; p=1.0), or venous thromboembolism (0% vs 0% vs 1%; p=1.0). Additionally, there were no differences in length of stay (p=0.18) or 30-day readmission rates (p=1.0). Finally, there were no significant differences in peri-operative outcomes when stratified by radical versus simple hysterectomy.DiscussionWaiting 6 weeks between cervical excisional procedure and robotic hysterectomy does not impact peri-operative complication rates. This suggests that the time from excisional procedure should not factor into surgical planning for those who undergo robotic hysterectomy.

Laryngeal Web in the Pediatric Population: Evaluation and Management

2019 ◽  
Vol 162 (2) ◽  
pp. 234-240 ◽  
Author(s):  
Claire M. Lawlor ◽  
Natasha D. Dombrowski ◽  
Roger C. Nuss ◽  
Reza Rahbar ◽  
Sukgi S. Choi
Keyword(s):  
Pediatric Population ◽  
Care Center ◽  
Tertiary Care ◽  
Case Series ◽  
22Q11.2 Deletion Syndrome ◽  
Deletion Syndrome ◽  
Retrospective Case ◽  
Presenting Symptoms ◽  
Subglottic Extension ◽  
Type 3

Objective To discuss the presentation, evaluation, and management of pediatric laryngeal web. Study Design Retrospective case series. Setting Single tertiary care center. Subjects All patients with laryngeal web at Boston Children’s Hospital in the past 22 years. Methods No exclusion criteria. Charts mined for age at presentation, presenting symptoms, degree/location of web, associated syndromes, number/type of surgical procedures, and postoperative outcomes. Results Thirty-seven patients were included (13 male, 24 female). Average age at diagnosis was 3.7 years (0-19.5 years). Mean follow-up was 4.4 years (range, 0-16.4 years). There were 26 congenital webs (70.2%) and 11 acquired webs (29.8%). Presenting symptoms were vocal (29 patients, 78.4%) and respiratory (22 patients, 60%). Underlying syndromes or synchronous airway lesions included the following: premature (n = 5), congenital heart disease (n = 18), subglottic stenosis (n = 5), 22q11.2 deletion syndrome (n = 10), and recurrent respiratory papillomatosis (n = 4). There were 20 type 1 webs, 6 type 2 webs, 8 type 3 webs, and 3 type 4 webs; 10 had subglottic extension of the laryngeal web. Twelve patients were managed conservatively with observation. Eighty-four interventions were performed: 18 open and 66 endoscopic (sharp division, 32; dilation, 33; mitomycin C, 14; laser, 5; keel, 6; triamcinolone injection, 8; stent, 15; removal of granulation tissue, 5). Tracheotomy was required in 11 patients, and 5 patients were decannulated. Voice improved in 12 patients, with respiratory symptoms in 12 patients. Web recurred in 17 patients. One patient died due to airway complications. Conclusions Pediatric laryngeal web is an uncommon but challenging lesion. Patients need to be evaluated for comorbid syndromes and synchronous airway lesions. Management includes open and endoscopic procedures. Procedures should be tailored to the child’s presentation.

scholarly journals Pancreaticoduodenectomy: Volume is not Associated with Outcome within an Academic Health Care System

HPB Surgery ◽  
2008 ◽  
Vol 2008 ◽  
pp. 1-6 ◽  
Author(s):  
Micheal T. Schell ◽  
Anthony Barcia ◽  
Austin L. Spitzer ◽  
Hobart W. Harris
Keyword(s):  
Health Care ◽  
San Francisco ◽  
Medical Center ◽  
Care Center ◽  
Tertiary Care ◽  
Survival Rates ◽  
High Volume ◽  
Care Pathways ◽  
Complication Rates ◽  
Significant Difference

Hypothesis. Smaller and lower-volume hospitals can attain surgical outcomes similar to high-volume centers if they incorporate the expertise and health care pathways of high-volume centers. Setting. The academic tertiary care center, Moffit-Long Hospital (ML); the community-based Mount Zion Hospital (ZION); the San Francisco County General Hospital (SFGH); and the Veterans Affairs Medical Center of San Francisco (VAMC). Patients. 369 patients who underwent pancreaticoduodenectomy between October 1989 and June 2003 at the University of California, San Francisco (UCSF) affiliated hospitals. Interventions. Pancreaticoduodenectomy. Design. Retrospective chart review. To correct for the potentially confounding effect of small case volumes and event rates, data for SFGH, VAMC, and ZION was combined (Small Volume Hospital Group; SVHG) and compared against data for ML. Main Outcome Measures. Complication rates; three-year and five-year survival rates. Results. The average patient age and health, as determined by ASA score, were similar between ML and the SVHG. The postoperative complication rate did not differ significantly between ML and the SVGH (58.8% versus 63.1%). Patients that experienced a complication averaged 2.5 complications in both groups. The perioperative mortality rate was 4% for patients undergoing pancreaticoduodenectomy at either ML or the SVGH. Although the 3-year survival rate for patients with adenocarcinoma of the pancreas was nearly twice as high at ML (31.2% versus 18.3% at SVHG), there was no significant difference in the 5-year survival rates (19% at ML versus 18.3% at SVHG). Conclusions. Low-volume hospitals can achieve similar outcomes to high-volume tertiary care centers provided they import the expertise and care pathways necessary for improved results.

scholarly journals Five-years review of obstetric hysterectomy at tertiary care center

2020 ◽  
Vol 10 (1) ◽  
pp. 308
Author(s):  
Anita G. Pawar ◽  
Mangala A. Shinde ◽  
Sarasjothi M. ◽  
Priyanka B. Nemagouda
Keyword(s):  
Risk Factors ◽  
Maternal Morbidity ◽  
Care Center ◽  
Tertiary Care ◽  
Morbidity And Mortality ◽  
Transfusion Rate ◽  
Hypertensive Disorder ◽  
Complication Rates ◽  
Tertiary Care Center ◽  
Maternal Morbidity And Mortality

Background: Obstetric hysterectomy (OH) is indicated as last resort operation to save the life of the mother  and associated with high complication rates, so  requires a highly experienced and skilled medical team ,to solve any complication. Objective was to identify incidence, demographic profile, indications, risk factors, complications, maternal morbidity and mortality associated   with   obstetric hysterectomy.Methods: Retrospective   analytical study of 47 case records is done over period of last 5 years   from October 1st October 2015 to 30th September 2020 at VDGIMS, a tertiary care center, Latur. Results are expressed in frequency and percentages.Results: In our study, the rate of OH was 1.1/1000 deliveries. Most common (68%) age group was 21-30 yrs, majority (70%) were multipara, and booked (76%). Most common indication of OH was atonic PPH (65%), followed by traumatic PP, including rupture uterus (21%), and placenta acreta (10%). Most OH was performed on emergency basis (91%) and of subtotal type (95%). Major mode of delivery  was cesarean 65% and vaginal delivery in 21% cases. Most common risk factors were placental causes (55%), previous LSCS (48%) and hypertensive disorder (31%). High maternal morbidity in form of 100% blood transfusion rate, 93% ICU admission, inotropes and ventilator support in 59% cases and prolonged hospital stay in 75% cases seen. Most common complication were hemorrhagic shock 21%, DIC (29%), renal failure (12%) and septic shock (14%) with maternal death rate of 23% was noted.Conclusions: Obstetric hysterectomy is a necessary life-saving operation, but also associated with high maternal morbidity and mortality, which can be minimized with timely done procedure by experienced person.

scholarly journals AN OBSERVATIONAL STUDY ON ASSESSMENT OF POSTOPERATIVE COMPLICATIONS AMONG PERFORATION PERITONITIS USING CLAVIEN-DINDO CLASSIFICATION IN TERTIARY CARE CENTER OF CENTRAL INDIA

2021 ◽  
Vol 9 (02) ◽  
pp. 922-937
Author(s):  
Ankur Deshwali ◽  
◽  
Sanjay Prasad ◽  
Akhilesh Kumar Patel ◽  
Rohan Chaphekar ◽  
...  
Keyword(s):  
Observational Study ◽  
Abdominal Surgery ◽  
Care Center ◽  
Tertiary Care ◽  
P Value ◽  
Complication Rates ◽  
Medical College ◽  
Sri Aurobindo ◽  
Perforation Peritonitis

Introduction :Surgical team always tries to provide consistently low incidence of major complications for patient undergoing any operation. Clavien-Dindo (CD) classification is the simplest way of reporting all complications. The main aim of this study was to test the usefulness of Clavien-Dindo classification in patients undergoing the abdominal surgery. In this study Clavien-Dindo classification has been used for assessment of postsurgical complications after major abdominal surgery. Material and method: It was an observational study of all perforation peritonitis patients admitted in sri aurobindo medical college and post graduate institute between november 2017 to may 2019 (1 and 1/2 Year) on the basis of Clavien-Dindo classification. Results :This was an observational prospective study was carried out in Department of General Surgery, Sri Aurobindo Medical College and P.G. Institute, Indore, which includes total 60 patients of perforation peritonitis admitted and treated in the department, During the period of November 2017 to May 2019. In our study Most common symptoms in patients presenting with perforation is Abdominal pain in 60 (100%) patients. 45(75%) patients had constipation & obstipation, 41 (68.33%) patients had vomiting ,33(55%) of patients had fever 17 (28.33%) patients had abdominal distensions the other common symptoms. Out of 60 patients, all 60(100%) patients had abdominal tenderness and guarding, 47 (78.33%) patients had absent bowel sounds, 42(70%) patients had tachycardia, 26 (43.33%) patients had hypotension, 23 (38.33%) patients had tachypnoea and 21 (35%) patients had low urinary output. In 16 (26.6%) patients comorbid conditions were present. In 10 (16.66%) patients multiple perforations were found out of which only 01 (10%) patient is haemodynamically stable and 09 (90%) patients were unstable. Complication occurred in 09(90%) patients and no complication were only in 01 (10%) patients. In this group 04(40%) patients got discharged and 6(60%) patient expired. P Value was 0.001 which is significant. In our study most common site of perforation was gastric perforation 30(49.18%) Complication according to clavien -dindo classification 14 out of 60 (23.33%) patients had no complications, 4 (6.66%) had grade I complication, 5 (8.33%) had grade II complications, 12 (20%) had grade III complications, 11 (18.33%) had grade IV complications, and 14 (23.33%) had grade V complication rates. Conclusion :Perforation peritonitis is a life-threatening condition and requires urgent hospital care, resuscitation and surgery. Early resuscitation and surgery are required to decrease morbidity and mortality. On the basis of risk stratification in Peritonitis patients its management requires lots of expensive modalities, skill, monitoring and treatment to provide better care to the patient. For the classification of complications, a new system is proposed by Clavien–Dindo which is very helpful during perforation surgery.Clavien- Dindo classification helps us to distinguish a normal postoperative course and the severity of complications, which allows us to compare postoperative morbidity and evaluate the outcomes. We also recommend a larger study with a bigger sample size for better analysis of clavien-dindo classification of complications and to confirm the findings of our study.

scholarly journals Prevalence of hypothyroidism among patients with obstructive sleep apnea: A study in a tertiary care center

2021 ◽  
Vol 6 (3) ◽  
pp. 161-164
Author(s):  
D.S Sowjanya ◽  
M Ravindranath
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Epworth Sleepiness Scale ◽  
Care Center ◽  
Tertiary Care ◽  
Arousal Index ◽  
Obstructive Sleep ◽  
The Mean ◽  
Saturated Oxygen

Obstructive sleep apnea is a common disorder wherein there are recurrent episodes of sleep disordered breathing resulting in disrupted sleep and other sequelae. The symptoms of hypothyroidism are very similar to OSA, a number of studies have been performed to analyze their association with conflicting results. A questionnaire based on the Wisconsin Sleep Apnea questionnaire for quality of sleep, sleep pattern, symptoms during sleep, snoring were asked to 118 patients included in the study. The day time sleep patterns were assessed by the Epworth Sleepiness scale. Polysomnography testing, Saturated oxygen levels, sleep efficiency and arousal index were also done for all the patients. Blood was collected for the detection of thyroid hormones. There were 82 (69.5%) males and 36 (30.5%) females on the present study out of 118 patients. The mean age of the patients under study was 53.91 ± 4.69 years, the weight was 89.48 ± 12.83 kgs and the BMI was 34.86 ± 6.11. Amongst the patients with OSA and hypothyroid, the apnea hypoapnea index was 66.22 ± 18.31 episodes per hour, and Epworth sleepiness scale was 15.18 ± 5.26 while in patients with OSA and without hypothyroid, it was 24.17 ± 6.29 and 8.25 ± 5.82 respectively. Our study shows a significant association between OSA and hypothyroidism among patients, thus having a considerable implications in managing the thyroid condition of the patients.

Comparison of Velopharyngeal Growth Patterns between Cleft Lip and/or Palate Patients Requiring or Not Requiring Pharyngeal Flap Surgery

1994 ◽  
Vol 31 (6) ◽  
pp. 452-460 ◽  
Author(s):  
Mohammad Mazaheri ◽  
Athanasios E. Athanasiou ◽  
Ross E. Long
Keyword(s):  
Cleft Palate ◽  
Soft Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Growth Curves ◽  
Growth Patterns ◽  
Flap Surgery ◽  
Velopharyngeal Incompetence ◽  
Lateral Cephalograms ◽  
Pharyngeal Flap

This investigation compares the patterns of velopharyngeal growth in cleft lip and/or palate patients. Those who had velopharyngeal competence and acceptable speech are compared with those who presented with velopharyngeal incompetence requiring pharyngeal flap surgery or prosthesis later. Lateral cephalograms of 30 cleft palate only (CPO), 35 unilateral cleft lip and palate (UCLP), and 20 bilateral cleft lip and palate (BCLP) children of the Lancaster Cleft Palate Clinic were studied. These records were taken at 6 month intervals during the first 2 postnatal years and annually thereafter up to 6 years of age. Soft tissue landmark points in the velopharyngeal region were digitized. Length and thickness of the soft palate and height and depth of the nasopharynx were measured. Evaluation of the growth curves of these four cephalometric variables indicated only two significant differences between children who later required pharyngeal flap surgery and those who did not. These differences were found in the growth in length of the soft palate of the CPO group and in the growth in depth of the nasopharynx of the BCLP group. Based on the present cephalometric data, it is Impossible to predict at an early age those cleft lip and/or palate patients who will later require pharyngeal flaps.

scholarly journals Respiratory Complications following Tonsillectomy/UPPP: Is Step-Down Monitoring Necessary?

2003 ◽  
Vol 82 (8) ◽  
pp. 628-632 ◽  
Author(s):  
Eric M. Gessler ◽  
Peter C. Bondy
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Average Length ◽  
Care Center ◽  
Tertiary Care ◽  
Retrospective Chart Review ◽  
Average Length Of Stay ◽  
Obstructive Sleep ◽  
Respiratory Event ◽  
Step Down

We conducted a study to determine if the risk of airway compromise following tonsillectomy with uvulopalatopharyngoplasty justifies the added cost and inconvenience of step-down monitoring in an intensive care unit. We performed a retrospective chart review of 130 patients with obstructive sleep apnea who had undergone isolated tonsillectomy with uvulopalatopharyngoplasty at our tertiary care center. The average length of stay in the step-down unit was 18 hours. We found that only eight of these patients (6.2%) had a postoperative desaturation level of less than 90%, including three of 12 patients (25%) who had comorbid conditions. No patient had an adverse respiratory event. We conclude that step-down monitoring in an intensive care unit is not necessary, although caution should be exercised in monitoring patients with comorbidities because they appear to be more prone to desaturation. A complete lack of adverse respiratory events has not been reported in previous studies.

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