NCT05581771

Brief Summary

This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

9 days

First QC Date

October 4, 2022

Last Update Submit

July 13, 2024

Conditions

Keywords

Noninvasive positive pressure ventilationAmyotrophic lateral sclerosisAdherence

Outcome Measures

Primary Outcomes (1)

  • Success of NIPPV

    The success of NIPPV application was defined empirically as use of ≥ 2 hours per day and the failure as use of \< 2 hours for a day or conversion to invasive positive pressure ventilation via tracheostomy or refuse to apply NIPPV during hospitalization.

    through intervention completion, with an average of 10 days

Secondary Outcomes (1)

  • Lenght of stay

    through intervention completion, with an average of 10 days

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALS patients who were admitted for applying non-invasive positive pressure ventilation initially.

You may qualify if:

  • Patients fulfilling the El Escorial World Federation criteria for probable, or definite ALS
  • Aged ≥ 19 years
  • Patients who performed blood gas analysis including venous blood gas and arterial blood gas before NIPPV application.

You may not qualify if:

  • Patients who had experience in applying the NIPPV or currently using NIPPV
  • Patients who applied in outpatient settings
  • Patients who did not perform blood gas analysis before NIPPV application
  • Patietns who had a history of asthma or COPD,
  • Patients who didn't have any record of NIPPV application time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jaewon Beom, PhD

    Department of Rehabilitation Medicine, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 17, 2022

Study Start

October 18, 2022

Primary Completion

October 27, 2022

Study Completion

October 4, 2023

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations