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Factors Associated With Success of NIPPV in ALS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05581771
Recruitment Status : Active, not recruiting
First Posted : October 17, 2022
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jaewon Beom, Seoul National University Bundang Hospital

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

Condition or disease
ALS

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
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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study
Actual Study Start Date : October 18, 2022
Actual Primary Completion Date : October 27, 2022
Estimated Study Completion Date : September 22, 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Lenght of stay [ Time Frame: through intervention completion, with an average of 10 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05581771


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jaewon Beom, PhD Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
More Information
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Responsible Party: Jaewon Beom, Clinical Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05581771    
Other Study ID Numbers: B-2210-786-107
First Posted: October 17, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaewon Beom, Seoul National University Bundang Hospital:
Noninvasive positive pressure ventilation
Amyotrophic lateral sclerosis
Adherence
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases