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Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Sponsor
Anne Kathrine Staehr-Rye (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05829330
Collaborator
(none)
46
Enrollment
2
Arms
19.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital

The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.

Condition or Disease Intervention/Treatment Phase
  • Other: Outpatient
  • Other: Hospitalization
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Outpatient

Outpatient initiation of non-invasive mechanical ventilation

Other: Outpatient
Outpatient Initiation of noninvasive mechanical ventilation
Placebo Comparator: Hospitalization

Initiation of non-invasive mechanical ventilation during hospitalization

Other: Hospitalization
Initiation of non-invasive mechanical ventilation during hospitalization

Outcome Measures

Primary Outcome Measures

  1. Use of non-invasive mechanical ventilation [The 83th to the 90th day after initiation of non-invasive mechanical ventilation]

    Use of non-invasive mechanical ventilation in minutes per day

Secondary Outcome Measures

  1. Patient satisfaction with the treatment [Measured at the 3 months follow-up visit]

    Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5)

  2. Patient satisfaction with the proces in relation to the start of the treatment [Measured at the 3 months follow-up visit]

    Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age > 18 years

  • Diagnosed with amyotrophic lateral sclerosis

  • Indication for start of non-invasive mechanical ventilation

Exclusion Criteria:

  • No informed consent

  • Does not understand Danish or English

  • Indication for invasive mechanical ventilation

  • No morning baseline PCO2

  • Hospitalization

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Anne Kathrine Staehr-Rye

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Kathrine Staehr-Rye, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05829330
Other Study ID Numbers:
  • H-23005093
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis

Study Results

No Results Posted as of Apr 25, 2023