ALSNCT05581771
Factors Associated With Success of NIPPV in ALS Patients
An observational study of ALS, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- ALS
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2022to 4 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALS patients who were admitted for applying non-invasive positive pressure ventilation initially.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, 13620
About this study
Official title: Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study
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.
- Conditions
- ALS
- Keywords
- Noninvasive positive pressure ventilation, Amyotrophic lateral sclerosis, Adherence
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through intervention completion, with an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start18 Oct 2022
- Primary completion27 Oct 2022
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaewon Beom, Seoul National University Bundang Hospital
- Investigators
- Jaewon Beom, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581771
- Sponsor's protocol ID
- B-2210-786-107
- Status last verified
- Jul 2024
- First submitted
- 4 Oct 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05581771
- Acronym / sponsor ID
- B-2210-786-107
- Conditions
- ALS
- Keywords
- Noninvasive positive pressure ventilation, Amyotrophic lateral sclerosis, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALS patients who were admitted for applying non-invasive positive pressure ventilation initially.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success of NIPPV
Time frame: through intervention completion, with an average of 10 days
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.
1 secondary outcome
Lenght of stay
Time frame: through intervention completion, with an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaewon Beom, PhD principal investigator
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of NIPPV (time frame: through intervention completion, with an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.