Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated ALS Patients in Portugal and in Norway
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|ClinicalTrials.gov Identifier: NCT03887338|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Other: Transnasal Fiberoptic Laryngoscopy||Not Applicable|
ALS, amyotrophic lateral sclerosis, is a rare and fatal disease causing gradual loss of motor neurons and thus loss of function in all skeletal muscle, eventually also in the breathing muscles, leading to respiratory failure and ultimately death. There is no causal treatment. The treatment provided aims to improve life quality as long as possible. Non-invasive ventilation (NIV) compensates for respiratory failure as breathing deteriorates.
ALS patients with bulbar innervated muscle dysfunction (mouth, tongue, jaw, throat, larynx) have poor compliance to the use of NIV. It is not completely understood why bulbar ALS patients fails NIV, although the upper airways have been a suggested cause also of this treatment failure. The investigators in the Norwegian study group has previously examined laryngeal response patterns (using transnasal fiberoptic laryngoscopy ) during mechanically assisted cough in ALS. The studies revealed that Transnasal fiberoptic laryngoscopy was safely performed with ongoing mechanically assisted cough, and it appeared a feasible tool to visualize the laryngeal responses to mechanical cough therapy.
The further hypothesis is that the use of transnasal fiberoptic laryngoscopy during ongoing NIV titration could improve the compliance of NIV treatment in ALS.
Since ALS is a relatively rare disease and it is difficult to perform large clinical studies, a project group has been established and agreed to a common protocol of a population-based multicenter-study including two hospitals, in Bergen in Norway and Vila Real in Portugal.
Aims of the study are:
To investigate the feasibility of video-recorded Transnasal fiberoptic laryngoscopic evaluation of the upper airways applied during NIV titration, and to describe the upper airway responses to NIV treatment in patients with ALS.
To explore whether the endoscopic view of the upper airways will influence the titration of NIV settings in ALS patients.
To explore whether NIV titration with endoscopic evaluation will influence NIV compliance and ventilation effectiveness in ALS patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All the subjects will receive the same intervention, and they will be examined both prior to the intervention, one month after and three months after the intervention. They will act as they own controls.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated Amyotrophic Lateral Sclerosis (ALS) Patients in Portugal and in Norway|
|Actual Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
NIV settings titration
Transnasal Fiberoptic Laryngoscopy will be used during ongoing NIV setting titration. Aim is to titrate NIV setting to be more optimal for laryngeal responses.
Other: Transnasal Fiberoptic Laryngoscopy
Use of Transnasal Fiberoptic Laryngoscopy during NIV titration to optimalize the NIV settings to laryngeal responses during the NIV treatment.
- Apnoea-hypopnea index (AHI) [ Time Frame: Baseline, one and three months after the intervention. ]Change in number of apnea and hypopnea events per hour of sleep
- Time of NIV use [ Time Frame: Baseline, one and three months after the intervention. ]Change in median daily and average daily of hours, minutes
- NIV Leaks [ Time Frame: Baseline, one and three months after the intervention. ]Change in median and 95%
- NIV time of use [ Time Frame: Baseline, one and three months after the intervention. ]Change in % of time of use > than 4 hours/day
- NIV compliance [ Time Frame: Baseline, one and three months after the intervention. ]Change in number of interruptions, complains and ventilator adjustments
- Night-time pulseoximeter [ Time Frame: Baseline, one and three months after the intervention. ]Change in oxygen saturation of patients blood
- Night-time capnography [ Time Frame: Baseline, one and three months after the intervention. ]Change in concentration or partial pressure of carbon dioxide in the respiratory gases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887338
|Contact: Tiina M Andersen, PhDfirstname.lastname@example.org|
|Contact: Bebiana Conde, PhD email@example.com|
|Norwegian National Advisory Unit on Long-term Mechanical Ventilation at Thoracic Department, Haukeland University Hospital||Recruiting|
|Bergen, Hordaland, Norway, 5021|
|Contact: Tiina M Andersen, PhD firstname.lastname@example.org|
|Principal Investigator: Tiina M Andersen, PhD|
|Sub-Investigator: Maria Vollsæter, PhD|
|Sub-Investigator: Ove Fondenes, MD|
|Centro Hospitalar Tras-os-Montes e Alto Douro||Recruiting|
|Vila Real, Portugal|
|Contact: Bebiana Conde, PhD fellow email@example.com|
|Principal Investigator: Bebiana Conde, PhD fellow|
|Sub-Investigator: Joao Winck, Professor|
|Principal Investigator:||Tiina M Andersen, PhD||Haukeland University Hospital|
|Principal Investigator:||Bebiana Conde, PhD fellow||Centro Hospitalar Tras-os-Montes e Alto Douro|