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Completed

NCT Number: NCT05581771

Factors Associated With Success of NIPPV in ALS Patients

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

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Key information

Conditions

ALS Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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