Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
Primary Purpose
Obstructive Sleep Apnoea, Sleep-Disordered Breathing
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Short-time diagnostic anaesthesia
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnoea focused on measuring drug-induced sleep endoscopy, obstructive sleep apnoea, VOTE classification, AHI, BMI
Eligibility Criteria
Inclusion Criteria:
- 18-65 years
- obstructive sleep apnoea (mild, moderate Apnea-Hypopnea Index (AHI) <15)
- severe OSA - failed CPAP treatment
- severe OSA - patients whorefused CPAP
Exclusion Criteria:
- ASA 4 (classification of the American Society of Anesthesiologists)
- pregnancy
- propofol or midazolam allergies
- other significant disease with current decompensation
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short-time diagnostic anaesthesia
Arm Description
The study population will consist of patients with obstructive sleep apnoea, which will be classified as mild, moderate, severe (patients who failed or refused primary CPAP treatment). The patients will undergo a short-time general anaesthesia in order to diagnose OSA when relaxed.
Outcomes
Primary Outcome Measures
Comparison of indication for surgery based upon ENT examination before and after DISE.
Indication for surgery made according to otorhinolaryngology examination before DISE and after DISE will be compared. There exist a defined number of surgical procedures for which the patient may be indicated, indication for individual surgical procedures will be compared before and after DISE.
Secondary Outcome Measures
Full Information
NCT ID
NCT02855515
First Posted
July 26, 2016
Last Updated
October 5, 2020
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT02855515
Brief Title
Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
Official Title
The Role of Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea, Sleep-Disordered Breathing
Keywords
drug-induced sleep endoscopy, obstructive sleep apnoea, VOTE classification, AHI, BMI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short-time diagnostic anaesthesia
Arm Type
Experimental
Arm Description
The study population will consist of patients with obstructive sleep apnoea, which will be classified as mild, moderate, severe (patients who failed or refused primary CPAP treatment). The patients will undergo a short-time general anaesthesia in order to diagnose OSA when relaxed.
Intervention Type
Procedure
Intervention Name(s)
Short-time diagnostic anaesthesia
Intervention Description
Patients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed.
Primary Outcome Measure Information:
Title
Comparison of indication for surgery based upon ENT examination before and after DISE.
Description
Indication for surgery made according to otorhinolaryngology examination before DISE and after DISE will be compared. There exist a defined number of surgical procedures for which the patient may be indicated, indication for individual surgical procedures will be compared before and after DISE.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years
obstructive sleep apnoea (mild, moderate Apnea-Hypopnea Index (AHI) <15)
severe OSA - failed CPAP treatment
severe OSA - patients whorefused CPAP
Exclusion Criteria:
ASA 4 (classification of the American Society of Anesthesiologists)
pregnancy
propofol or midazolam allergies
other significant disease with current decompensation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Komínek, prof.MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaroslava Hybášková, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24972543
Citation
Aktas O, Erdur O, Cirik AA, Kayhan FT. The role of drug-induced sleep endoscopy in surgical planning for obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2015 Aug;272(8):2039-43. doi: 10.1007/s00405-014-3162-8. Epub 2014 Jun 28.
Results Reference
background
PubMed Identifier
20559476
Citation
Campanini A, Canzi P, De Vito A, Dallan I, Montevecchi F, Vicini C. Awake versus sleep endoscopy: personal experience in 250 OSAHS patients. Acta Otorhinolaryngol Ital. 2010 Apr;30(2):73-7.
Results Reference
background
PubMed Identifier
24167821
Citation
Cavaliere M, Russo F, Iemma M. Awake versus drug-induced sleep endoscopy: evaluation of airway obstruction in obstructive sleep apnea/hypopnoea syndrome. Laryngoscope. 2013 Sep;123(9):2315-8. doi: 10.1002/lary.23881.
Results Reference
background
PubMed Identifier
24376297
Citation
DE Corso E, Fiorita A, Rizzotto G, Mennuni GF, Meucci D, Giuliani M, Marchese MR, Levantesi L, Della Marca G, Paludetti G, Scarano E. The role of drug-induced sleep endoscopy in the diagnosis and management of obstructive sleep apnoea syndrome: our personal experience. Acta Otorhinolaryngol Ital. 2013 Dec;33(6):405-13.
Results Reference
background
PubMed Identifier
24859484
Citation
De Vito A, Carrasco Llatas M, Vanni A, Bosi M, Braghiroli A, Campanini A, de Vries N, Hamans E, Hohenhorst W, Kotecha BT, Maurer J, Montevecchi F, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sedation endoscopy (DISE). Sleep Breath. 2014 Sep;18(3):453-65. doi: 10.1007/s11325-014-0989-6. Epub 2014 May 26.
Results Reference
background
PubMed Identifier
21614467
Citation
Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26.
Results Reference
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Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
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