ClinicalTrials.gg
CompletedNCT05581771Updated Jul 16, 2024

Factors Associated With Success of NIPPV in ALS Patients

An observational study in ALS, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
51
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Patients with ALS who were admitted to a tertiary hospital for initially applying non-invasive positive pressure ventilation (NIPPV). The objective of this study was to investigate factors associated with optimal NIPPV initiation and adherence, and to assess the long-term effects of NIPPV adherence in ALS patients.

02

Conditions studied

  • ALS

Keywords

  • Noninvasive positive pressure ventilation
  • Amyotrophic lateral sclerosis
  • Adherence
03

In context

Amyotrophic Lateral Sclerosis

1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.

This study's enrollment of 51 is below the median of 103 across 272 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
51 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: through intervention completion, with an average of 10 days

Secondary outcomes

  1. Lenght of stay

    The length of stay (LOS) was defined as the interval between admission and hospital discharge, and calculated as the number of midnights between admission and discharge from the hospital.

    Time frame: through intervention completion, with an average of 10 days

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, 13620, South Korea
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in Oct 2022, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2022
First posted
Oct 17, 2022
StartActual
Oct 18, 2022
Primary completionActual
Oct 27, 2022
CompletionActual
Oct 4, 2023
Last update
Jul 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05581771
Responsible party
Jaewon Beom (Clinical Associate Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Oct 17, 2022
Start date
Oct 18, 2022
Primary completion
Oct 27, 2022
Completion
Oct 4, 2023
Last update
Jul 16, 2024

Study contacts

Jaewon Beom, PhD
principal investigator · Department of Rehabilitation Medicine, Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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