Factors Associated With Success of NIPPV in ALS Patients

Completed

• Conditions: ALS

• Registration Number: NCT05581771
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Study Start: 2022-10-18
• Primary Completion: 2022-10-27
• Study Completion: 2023-10-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of NIPPV	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

Name	Time	Method
Lenght of stay	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of