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

NCT03887338 | Unknown DMC

• 2 other identifiers: 2018/130639/2016
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Noninvasive Ventilation; Laryngoscopy

Outcome Measures

Primary Outcomes (5)

• Apnoea-hypopnea index (AHI)

  Change in number of apnea and hypopnea events per hour of sleep

  Baseline, one and three months after the intervention.

• Time of NIV use

  Change in median daily and average daily of hours, minutes

  Baseline, one and three months after the intervention.

• NIV Leaks

  Change in median and 95%

  Baseline, one and three months after the intervention.

• NIV time of use

  Change in % of time of use \> than 4 hours/day

  Baseline, one and three months after the intervention.

• NIV compliance

  Change in number of interruptions, complains and ventilator adjustments

  Baseline, one and three months after the intervention.

Secondary Outcomes (2)

• Night-time pulseoximeter

  Baseline, one and three months after the intervention.

• Night-time capnography

  Baseline, one and three months after the intervention.

Study Arms (1)

NIV settings titration

OTHER

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

Interventions

Transnasal Fiberoptic Laryngoscopy OTHER

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

NIV settings titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed Amyotrophic Lateral Sclerosis (ALS) due to El Escorial criteria
• Must have already established Non-invasive ventilation (NIV)

You may not qualify if:

• Ages under 18 years
• Unstable ischemic heart disease
• Oncological disease
• Ventilatory support dependency (more than 16h per day)

Sponsors & Collaborators

• Tiina Maarit Andersen: lead
• University of Trás-os-Montes and Alto Douro: collaborator
• Universidade do Porto: collaborator
• Haukeland University Hospital: collaborator

Study Sites (2)

Norwegian National Advisory Unit on Long-term Mechanical Ventilation at Thoracic Department, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Centro Hospitalar Tras-os-Montes e Alto Douro

Vila Real, Portugal

Location

Related Publications (5)

• Andersen T, Sandnes A, Brekka AK, Hilland M, Clemm H, Fondenes O, Tysnes OB, Heimdal JH, Halvorsen T, Vollsaeter M, Roksund 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.

  PMID: 27174631 BACKGROUND

• Andersen TM, Sandnes A, Fondenes O, Nilsen RM, Tysnes OB, Heimdal JH, Clemm HH, Halvorsen T, Vollsaeter M, Roksund 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.

  PMID: 29666294 BACKGROUND

• Andersen TM, Sandnes A, Fondenes O, Clemm H, Halvorsen T, Nilsen RM, Tysnes OB, Heimdal JH, Vollsaeter M, Roksund 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. No abstract available.

  PMID: 30389835 BACKGROUND

• Conde B, Martins N, Brandao 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.

  PMID: 31000441 BACKGROUND

• Andersen TM, Halvorsen T, Fondenes O, Heimdal JH, Roksund OD, Vollsaeter M, Roksund OD. Larynx: The Complex Gateway to the Lungs. Respir Care. 2019 Jul;64(7):866-869. doi: 10.4187/respcare.06989. No abstract available.

  PMID: 31243162 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tiina M Andersen, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Bebiana Conde, PhD fellow

  Centro Hospitalar Tras-os-Montes e Alto Douro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Respiratory Physiotherapist, PhD

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 22, 2019
• Study Start: March 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); PT (1)