Clinical trial NCT05483244: Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
Official title: Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
Respiratory Insufficiency
Keywords: early neurological rehabilitation
weaning strategy
weaning success
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurological main diagnoses, who admitted to early neurological rehabilitation and are under mechanical ventilation.

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.

Eligibility criteria: Inclusion Criteria (continuous weaning group):

* mechanical ventilation at admission to neurological rehabilitation
* weaned by a continuous or discontinuous weaning strategy

Exclusion Criteria:

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

Primary outcomes:
measure: weaning success
timeFrame: through study completion, an average of 70 days
Secondary outcomes:
measure: weaning duration
timeFrame: through study completion, an average of 70 days
Other outcomes:
Locations:
city: Hessisch Oldendorf
country: Germany
facility: Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
state: Lower Saxony
Study officials:
affiliation: BDH-Klinik Hessisch Oldendorf
name: Simone B Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
citation: Teismann IK, Oelschlager C, Werstler N, Korsukewitz C, Minnerup J, Ringelstein EB, Dziewas R. Discontinuous versus Continuous Weaning in Stroke Patients. Cerebrovasc Dis. 2015;39(5-6):269-77. doi: 10.1159/000381222. Epub 2015 Apr 8.
citation: Vitacca M, Vianello A, Colombo D, Clini E, Porta R, Bianchi L, Arcaro G, Vitale G, Guffanti E, Lo Coco A, Ambrosino N. Comparison of two methods for weaning patients with chronic obstructive pulmonary disease requiring mechanical ventilation for more than 15 days. Am J Respir Crit Care Med. 2001 Jul 15;164(2):225-30. doi: 10.1164/ajrccm.164.2.2008160.
citation: Matic I, Danic D, Majeric-Kogler V, Jurjevic M, Mirkovic I, Mrzljak Vucinic N. Chronic obstructive pulmonary disease and weaning of difficult-to-wean patients from mechanical ventilation: randomized prospective study. Croat Med J. 2007 Feb;48(1):51-8.