Factors Associated With Success of NIPPV in ALS Patients

ALS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05581771
• Other study ID #: B-2210-786-107
• Status: Active, not recruiting
• Start date: October 18, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: October 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: September 22, 2023
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through intervention completion, with an average of 10 days
Secondary	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.	through intervention completion, with an average of 10 days