Sleep-Disordered Breathing Clinical Trial
Official title:
The Role of Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
The main diagnostic challenge in patients with OSA (obstructive sleep apnea) is to determine the location of obstruction of the upper airway during sleep. This is so, because the otorhinolaryngology examination, which states probable site of obstruction of upper airways, is performed in the awake status. Therefore, drug-induced sleep endoscopy (DISE) has been introduced in the diagnostic algorithm of OSA patients during the last decade. The advantage of DISE is, that the collapse of upper airways, which is not visible during the awake status can be observed and targeted therapy according to the location and degree of obstruction of the upper airway can be applied. As a result, higher treatment success in patients with OSA can be reached.
Materials and Methods The study was approved by the Institutional Ethics Committee and
performed in accordance with the Declaration of Helsinki, good clinical practice, and
applicable regulatory requirements. Informed written consent was obtained from all
participants before initiation of any procedure.
• History, otorhinolaryngology examination, polysomnography Patient history will be taken
with emphasis on snoring and OSA symptoms. Daytime sleepiness will be assessed using the
Epworth Sleepiness Scale. Moreover, patients will be asked to grade the severity of snoring
on a 10-point Visual Analogue Scale (0 = no snoring, 10 = extreme snoring). The body mass
index (BMI) will be calculated.
Otorhinolaryngology examination, focusing on nasal, pharyngeal and laryngeal pathologies
(enlargement of uvula, soft palate webbing, enlargement of palatal tonsils, base of the
tongue hypertrophy, visibility of vallecula, pathology of epiglottis), will be performed.
Thereafter, each patient will undergo polysomnography and patients will be divided according
to the severity of OSA into three groups (mild OSA - 5 < AHI ≤ 15, moderate OSA 15 < AHI ≤
25, and severe OSA with AHI > 25 events per hour of sleep).
According to history, otorhinolaryngology examination and polysomnography, presumably site of
obstruction will be stated and therapeutic plan will be designated. Patients with severe OSA
will be sent for CPAP (continuous positive airway pressure) treatment, whereas surgery will
be recommended for patients with mild and moderate OSA.
• Drug-Induced sleep endoscopy
- Indication and contraindication to DISE DISE will be indicated in patients with mild and
moderate OSA and in those with severe OSA who will fail or refuse CPAP treatment. All these
patients will be potentially planned for surgery and will have to agree with the surgical
treatment.
Patients with ASA (American Society of Anesthesiology) score above 4, as well as patients
with central apnea and propofol or midazolam allergies, will be excluded from the study.
- Premedication Patients will be pre-medicated with a combination of 5 mg midazolam and
0,5 mg atropine intramuscularly 30 minutes before DISE.
- Procedure Patients will be lying in a supine position on an operation table, the lights
will be dimmed and the room quiet to minimize awaking stimuli. Patients will be
standardly monitored: ECG (electrocardiogram), blood oxygen saturation, non-invasive
blood pressure, and depth of anesthesia will be monitored by bispectral index (BIS).
Local anesthesia of nasal cavity will be performed by Lidocaine 10%, 2 sprays into each
nostril.
Anaesthesia will be induced by intravenous bolus of propofol 1 mg per kg of ideal body
weight, and maintained by repeated boluses of propofol 10-20 mg every 3-5 minutes for the
target BIS (Bispectral Index) value of 50-70. Once the patient reaches a satisfactory level
of sedation, a flexible fiber optic. Intubation scope 3.7mm x 65cm coated with anti-condense
will be introduced into the nasal cavity. The nasal passage, nasopharynx, velum, oropharynx
(including tonsils), tongue base, epiglottis, and larynx will be observed. The length of
examination will be 15 minutes minimal in order to detect the obstruction. DISE findings will
be reported using the VOTE classification system according to Kezirian. Accordingly,
localization of upper airways obstructions will be done.
At the end of endoscopy a jaw thrust (or Esmarch maneuver) will be performed. The mandible
will be gently advanced up to 5 mm. The manoeuver will be evaluated as successful when the
enlargement of upper airway will be observed and disappearance of apnea mimicking the effect
of mandibular repositioning appliance (MRA).
After finishing of endoscopy, patients will be awakened to full consciousness in the
operating room and then transferred to recovery room for 1-hour observation.
• Evaluation of changes in indication for site of surgery Indication for surgery made
according to otorhinolaryngology examination before DISE and after DISE will be compared.
Changes will be noted and the number of patients will be calculated using percentage.
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