SKUP3 randomised controlled trial: polysomnographic results after uvulopalatopharyngoplasty in selected patients with obstructive sleep apnoea.

OBJECTIVE: To assess the 6-month efficacy of uvulopalatopharyngoplasty (UPPP) compared with expectancy in selected patients with obstructive sleep apnoea syndrome (OSAS). DESIGN: A prospective single-centre randomised controlled trial with two parallel arms stratified by Friedman stage and body mass index (BMI). PARTICIPANTS: 65 consecutive patients with moderate to severe OSAS (apnoea-hypopnoea index (AHI) ≥15 events/h sleep), BMI <36 kg/m(2), Epworth sleepiness scale ≥8, Friedman stage I or II. INTERVENTION: Surgical treatment with UPPP. The control group underwent UPPP after a delay of 6 months. OUTCOMES: Changes in AHI and other polysomnography parameters at baseline compared with the 6-month follow-up. RESULTS: All patients (32 in the intervention group and 33 in the control group) completed the trial. The mean (SD) AHI in the intervention group decreased significantly (p<0.001) by 60% from 53.3 (19.7) events/h to 21.1 (16.7) events/h . In the control group the mean AHI decreased by 11% from 52.6 (21.7) events/h to 46.8 (22.8) events/h, with a significant difference between the groups (p<0.001). The mean time in the supine position and the BMI were unchanged in both groups. Subgroup analyses for Friedman stage, BMI group and tonsil size all showed significant reductions in AHI in the intervention group compared with controls. There were no severe complications after surgery. CONCLUSIONS: This trial demonstrates the efficacy of UPPP in treating selected patients with OSAS with a mean reduction in AHI of 60% compared with 11% in controls, a highly significant and clinically relevant difference between the groups. TRIAL REGISTRATION NUMBER: NCT01659671.

Clinical use and material wear of polymeric tracheostomy tubes.

OBJECTIVES: The objectives were to compare the duration of use of polymeric tracheostomy tubes, i.e., silicone (Si), polyvinyl chloride (PVC), and polyurethane (PU), and to determine whether surface changes in the materials could be observed after 30 days of patient use. METHODS: Data were collected from patient and technical records for all tracheostomized patients attending the National Respiratory Center in Sweden. In the surface study, 19 patients with long-term tracheostomy were included: six with Bivona TTS Si tubes, eight with Shiley PVC tubes, and five with Trachoe Twist PU tubes. All tubes were exposed in the trachea for 30 days before being analyzed by scanning electron microscopy (SEM) and attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR). New tubes and tubes exposed in phosphate-buffered saline were used as reference. RESULTS: Si tubes are used for longer periods of time than those made of PVC (P<.0001) and PU (P=.021). In general, all polymeric tubes were used longer than the recommended 30-day period. Eighteen of the 19 tubes exposed in patients demonstrated, in one or more areas of the tube, evident surface changes. The morphologic changes identified by SEM correlate well with the results obtained by ATR-FTIR. CONCLUSIONS: Si tracheostomy tubes are in general used longer than those made of PVC and PU. Most of the tubes exposed in the trachea for 30 days suffered evident surface changes, with degradation of the polymeric chains as a result.

Quality-of-life evaluation of patients with neuromuscular and skeletal diseases treated with noninvasive and invasive home mechanical ventilation.

BACKGROUND: Home mechanical ventilation (HMV) is known to be a successful therapy for chronic respiratory insufficiency, with regard to long-term survival. However, the quality of life (QoL) of patients receiving HMV has not previously been systematically investigated. The purpose of this study was to assess the QoL of patients with neuromuscular disorders and skeletal deformities (ie, restrictive lung disease) receiving HMV. METHODS: Patients receiving HMV treated by tracheostomy or noninvasive ventilation (NIV). Three different, standardized, and validated questionnaires were used: the Sickness Impact Profile (SIP), the Health Index (HI), and the Sense of Coherence (SOC) scale. Underlying diseases were postpolio dysfunction (37%), neuromuscular disorder (20%), scoliosis (15%), and other diseases (28%). RESULTS: The group treated with tracheostomy had higher HI scores than the group treated with NIV. For the three main diagnosis groups treated with tracheostomy or NIV, the patients with postpolio dysfunction treated with tracheostomy had lower SIP scores than the patients with postpolio dysfunction treated with NIV. This was in contrast to the patients with neuromuscular disorders treated with tracheostomy, who had higher scores in the SIP, compared with patients with postpolio dysfunction treated with tracheostomy and patients with neuromuscular disorders treated with NIV. A SIP score > 10% indicates a functional disability of clinical importance, and a high score on the HI and SOC scale indicates good perceived health. For the three main diagnosis groups treated with NIV, the patients with scoliosis had no dysfunction of clinical importance (4.6 +/- 3.7) on the SIP score compared with patients with postpolio dysfunction (15.5 +/- 7.6) and patients with neuromuscular disorders (13.2 +/- 5.2) [mean +/- SD]. The men showed more dysfunction in the SIP score than the women. CONCLUSION: Patients receiving HMV reported a good perceived health, despite severe physical limitations. The patients with postpolio dysfunction and the patients with scoliosis treated with tracheostomy perceived the best health, compared with NIV for this diagnosis.

Uvulopalatopharyngoplasty versus laser uvulopalatoplasty: prospective long-term follow-up of self-reported symptoms.

No study to date has prospectively compared the results of uvulopalatopharyngoplasty (UPPP) and CO2 laser palatal surgery. This study investigates and compares outcomes in 121 consecutive patients suffering from rhonchopathy, the majority of whom reported apneas. Sixty-one patients underwent UPPP and 60 laser uvulopalatoplasty (LUPP). Patients were requested to assess the frequency of symptoms associated with obstructive sleep apnea syndrome prior to surgery, at 3-month follow-up and 5-8 years postoperatively. All symptoms were significantly improved for the two patient groups, both short and long term (p < 0.01) although short-term results were generally better. However, UPPP was superior to LUPP in terms of all clinical effect parameters. Although patients treated with UPPP had more severe symptoms preoperatively they also had a better long-term outcome. Side-effects such as minor swallowing disturbances were frequent, using either surgical modality, but few patients were bothered if surgery was successful.

Material wear of polymeric tracheostomy tubes: a six-month study.

OBJECTIVES: The objectives were to study long-term material wear of tracheostomy tubes made of silicone (Si), polyvinyl chloride (PVC), and polyurethane (PU) after 3 and 6 months of clinical use. STUDY DESIGN: The study has a prospective and comparative design. METHODS: Nineteen patients with long-term tracheostomy, attending the National Respiratory Center in Sweden, were included, n = 6 with Si tubes, n = 8 with PVC tubes, and n = 5 with PU tubes. The tubes were exposed to the local environment in the trachea for 3 and 6 months and analyzed by scanning electron microscopy, attenuated total reflectance Fourier transform infrared spectroscopy, and differential scanning calorimetry. RESULTS: All tubes revealed severe surface changes. No significant differences were established after 3 or 6 months of exposure between the various materials. The changes had progressed significantly after this period, compared to previously reported changes after 30 days of exposure. The results from all analyzing techniques correlated well. CONCLUSIONS: All tubes, exposed in the trachea for 3-6 months, revealed major degradation and changes in the surface of the material. Polymeric tracheostomy tubes should be changed before the end of 3 months of clinical use.