Factors Associated With Success of NIPPV in ALS Patients

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05581771

Collaborator

(none)

Enrollment

Location

11.1

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Oct 18, 2022

Actual Primary Completion Date :

Oct 27, 2022

Anticipated Study Completion Date :

Sep 22, 2023

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator: Jaewon Beom, PhD, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Oct 17, 2022

Last Update Posted:

Nov 1, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jaewon Beom, Clinical Associate Professor, Seoul National University Bundang Hospital

Noninvasive positive pressure ventilation

Amyotrophic lateral sclerosis

Adherence

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Nov 1, 2022