Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis

Completed

• Conditions: Neurologic Disorder; Respiratory Insufficiency
• Interventions: Other: continuous weaning; Other: discontinuous weaning

• Registration Number: NCT05483244
• Lead Sponsor: BDH-Klinik Hessisch Oldendorf

Brief Summary

To enable weaning from mechanical ventilation, two different strategies may be distinguished: continuous weaning and discontinuous weaning. There is a lack of evidence of the superiority of one of both strategies is currently weak among early neurological rehabilitation patients. To the best of our knowledge, only one study including stroke patients compared different weaning strategies and showed a significantly shorter duration of mechanical ventilation during continuous than during discontinuous weaning, which is in contrast to the results of the largest weaning study with patients on medical-surgical intensive care units. In addition, further inconsistent results were reported from studies with chronic obstructive pulmonary disease patients, which might be due to disease duration and/or duration of prior mechanical ventilation in the acute care hospital.

This small number of studies with controversial results indicates that there is a considerable need for further research. The current study intended to compare the rehabilitation outcome of early neurological rehabilitation patients, weaned by different strategies (continuous vs. discontinuous) through a matched-pair analysis.

Detailed Description

Early rehabilitation patients admitted in the year 2020 to the intensive care unit of the BDH-Clinic Hessisch Oldendorf were screened for continuous weaning strategy by a respiratory therapist, retrospectively. Selected patients and a matching patient with a continuous weaning strategy was then identified in the clinical database (years 2017 to 2020) to generate a matched-pair according to the following characteristics: age, gender, diagnosis and severity of disease (early rehabilitation barthel index upon admission).

All data was collected retrospectively. Pre-existing diseases, disease duration (days between onset of neurological disease and admission to early neurological rehabilitation facility) and duration of mechanical ventilation before admission to early neurological rehabilitation facility were collected from medical records of the referring hospital. The course of weaning was described by the duration of mechanical ventilation (total hours and number of days), the weaning success and the removal of tracheal cannula. In addition, further information ( length of stay, the duration and time point of the first spontanous breathing trial as well as the occurrence of adverse events during rehabilitation) was documented for every patient.

Data was analyzed by the Statistical Package for Social Sciences (SPSS; version 26). Descriptive statistics were done and presented as median and interquartile range (IQR, 25th and 75th percentiles). For categorical data, descriptive statistics were calculated as frequencies. Differences between groups (continuous vs. discontinuous weaning) were analyzed by Mann-Whitney U test or Chi²-Test. Correlation analyses were performed by Spearman. A p-value \<0.05 was considered as stastical significant.

Study Timeline

• Study Start: 2021-11-20
• Primary Completion: 2022-01-28
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-29
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

• pre-existing mechanical ventilation before disease onset
• mixed weaning strategies (continuous and discontinuous) during weaning process

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
continuous weaning group	continuous weaning	In the case of continuous weaning, spontaneous breathing trial was supported by the respirator, but the positive endexpiratory pressure was lowered to an individual level (between 5 and 10 mbar) resulting in very little pressure support.
discontinuous weaning group	discontinuous weaning	Patients of the discontinuous weaning group were disconnected from the respirator during the spontaneous breathing phases which could then take place via taken directly to the heat moist exchanger, high-flow therapy and/or speaking valve without pressure support by the respirator.

Primary Outcome Measures

Name	Time	Method
weaning success	through study completion, an average of 70 days	number of patients who could weaned sucessfully from mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
weaning duration	through study completion, an average of 70 days	duration of mechnaical ventilation (in hours)

Trial Locations

Locations (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf; 🇩🇪 Hessisch Oldendorf, Lower Saxony, Germany