Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated ALS Patients in Portugal and in Norway

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated Amyotrophic Lateral Sclerosis (ALS) Patients in Portugal and in Norway

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03887338
• Other study ID #: 2018/1306
• Secondary ID: 39/2016
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study examines if titration of Non-Invasive mechanical ventilation (NIV) settings during ongoing laryngoscopic visualization can improve the compliance of NIV in subjects with Amyotrophic Lateral Sclerosis (ALS). The study is a multicentre study between Norwegian National Advisory Unit on Long-term Mechanical Ventilation at the Thoracic Department, Haukeland University Hospital, Bergen, Norway and Centro Hospital Tras-os-Montes e Alto Douro, Vila Real, Portugal.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed Amyotrophic Lateral Sclerosis (ALS) due to El Escorial criteria

• Must have already established Non-invasive ventilation (NIV)

Exclusion Criteria:

• Ages under 18 years

• Unstable ischemic heart disease

• Oncological disease

• Ventilatory support dependency (more than 16h per day)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Transnasal Fiberoptic Laryngoscopy
Use of Transnasal Fiberoptic Laryngoscopy during NIV titration to optimalize the NIV settings to laryngeal responses during the NIV treatment.

Locations

Country	Name	City	State
Norway	Norwegian National Advisory Unit on Long-term Mechanical Ventilation at Thoracic Department, Haukeland University Hospital	Bergen	Hordaland
Portugal	Centro Hospitalar Tras-os-Montes e Alto Douro	Vila Real

Sponsors (4)

Lead Sponsor	Collaborator
Tiina Maarit Andersen	Haukeland University Hospital, Universidade do Porto, University of Trás-os-Montes and Alto Douro

Countries where clinical trial is conducted

Norway,  Portugal, 

References & Publications (5)

Andersen T, Sandnes A, Brekka AK, Hilland M, Clemm H, Fondenes O, Tysnes OB, Heimdal JH, Halvorsen T, Vollsæter M, Røksund OD. Laryngeal response patterns influence the efficacy of mechanical assisted cough in amyotrophic lateral sclerosis. Thorax. 2017 Mar;72(3):221-229. doi: 10.1136/thoraxjnl-2015-207555. Epub 2016 May 12. — View Citation

Andersen TM, Halvorsen T, Fondenes O, Heimdal JH, Røksund OD, Vollsæter M, Røksund OD. Larynx: The Complex Gateway to the Lungs. Respir Care. 2019 Jul;64(7):866-869. doi: 10.4187/respcare.06989. — View Citation

Andersen TM, Sandnes A, Fondenes O, Clemm H, Halvorsen T, Nilsen RM, Tysnes OB, Heimdal JH, Vollsæter M, Røksund OD. Laryngoscopy Can Be a Valuable Tool for Unexpected Therapeutic Response in Noninvasive Respiratory Interventions. Respir Care. 2018 Nov;63(11):1459-1461. doi: 10.4187/respcare.06674. — View Citation

Andersen TM, Sandnes A, Fondenes O, Nilsen RM, Tysnes OB, Heimdal JH, Clemm HH, Halvorsen T, Vollsæter M, Røksund OD. Laryngeal Responses to Mechanically Assisted Cough in Progressing Amyotrophic Lateral Sclerosis. Respir Care. 2018 May;63(5):538-549. doi: 10.4187/respcare.05924. Epub 2018 Apr 17. — View Citation

Conde B, Martins N, Brandão M, Pimenta AC, Winck JC. Upper Airway Video Endoscopy: Assessment of the response to positive pressure ventilation and mechanical in-exsufflation. Pulmonology. 2019 Sep - Oct;25(5):299-304. doi: 10.1016/j.pulmoe.2019.02.008. Epub 2019 Apr 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnoea-hypopnea index (AHI)	Change in number of apnea and hypopnea events per hour of sleep	Baseline, one and three months after the intervention.
Primary	Time of NIV use	Change in median daily and average daily of hours, minutes	Baseline, one and three months after the intervention.
Primary	NIV Leaks	Change in median and 95%	Baseline, one and three months after the intervention.
Primary	NIV time of use	Change in % of time of use > than 4 hours/day	Baseline, one and three months after the intervention.
Primary	NIV compliance	Change in number of interruptions, complains and ventilator adjustments	Baseline, one and three months after the intervention.
Secondary	Night-time pulseoximeter	Change in oxygen saturation of patients blood	Baseline, one and three months after the intervention.
Secondary	Night-time capnography	Change in concentration or partial pressure of carbon dioxide in the respiratory gases	Baseline, one and three months after the intervention.