- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483244
Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lower Saxony
-
Hessisch Oldendorf, Lower Saxony, Germany, 31840
- Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
discontinuous weaning group
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.
|
Each day, a respiratory therapist evaluated whether a spontaneous breathing trial could be performed. Patients of the discontinuous weaning group were disconnected from the respirator during the spontaneous breathing phases which could then take place via heat moist exchanger, high-flow therapy and/or speaking valve without pressure support by the respirator (spontaneous breathing trial with heat moist exchanger). Heart rate, respiratory rate, blood pressure and mental condition of the patient (i. e. stress, fear) were monitored carefully for five to ten minutes and the Rapid Shallow Breathing Index was calculated. If the patient could keep the Rapid Shallow Breathing Index stable under 105/min/l (without a significant increase) over five minutes, the spontaneous breathing trial was regarded as successful and the weaning could be started. The duration of spontaneous breathing trial was extended according to the individual situation of the patient. |
continuous weaning group
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.
|
Each day, a respiratory therapist evaluated whether a spontaneous breathing trial could be performed. 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 (spontaneous breathing trial trial under continuous positive airway pressure condition). Heart rate, respiratory rate, blood pressure and mental condition of the patient (i. e. stress, fear) were monitored carefully for five to ten minutes and the Rapid Shallow Breathing Index was calculated. If the patient could keep the Rapid Shallow Breathing Index stable under 105/min/l (without a significant increase) over five minutes, the spontaneous breathing trial was regarded as successful and the weaning could be started. The duration of spontaneous breathing trial was extended according to the individual situation of the patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weaning success
Time Frame: through study completion, an average of 70 days
|
number of patients who could weaned sucessfully from mechanical ventilation
|
through study completion, an average of 70 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weaning duration
Time Frame: through study completion, an average of 70 days
|
duration of mechnaical ventilation (in hours)
|
through study completion, an average of 70 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simone B Schmidt, Dr., BDH-Klinik Hessisch Oldendorf
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Weaning Strategy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Insufficiency
-
Hospital Israelita Albert EinsteinRecruitingRespiratory Insufficiency in ChildrenBrazil
-
Vyaire MedicalCompletedRespiratory Insufficiency in ChildrenUnited Kingdom, Poland, Netherlands
-
Vyaire MedicalCompletedRespiratory Insufficiency in ChildrenNetherlands, Poland
-
Shanghai 10th People's HospitalUnknownPatients With Respiratory InsufficiencyChina
-
The Affiliated Hospital of Qingdao UniversityNot yet recruitingRespiratory Insufficiency Requiring Mechanical VentilationChina
-
Erasme University HospitalCentre Hospitalier Régional de la CitadelleNot yet recruitingRespiratory Insufficiency Requiring Mechanical VentilationBelgium
-
Fondazione Salvatore MaugeriAzienda Ospedaliero, Universitaria Pisana; Ataturk Training and Research HospitalCompletedChronic Respiratory InsufficiencyItaly
-
ADIR AssociationSuspendedCOPD | Chronic Respiratory InsufficiencyFrance
-
Yolanda Lopez FernandezHospital Infantil Universitario Niño Jesús, Madrid, Spain; Dr. Negrin University... and other collaboratorsRecruitingAcute Respiratory InsufficiencySpain
-
Dr. Negrin University HospitalAsociación Científica Pulmón y Ventilación Mecánica; Consorcio Centro de Investigación...CompletedAcute Respiratory InsufficiencySpain
Clinical Trials on discontinuous weaning
-
University of Missouri-ColumbiaTerminated
-
Felix JF HerthDLR German Aerospace Center; University Hospital Heidelberg; Federal Joint Committee and other collaboratorsRecruitingWeaning | Invasive VentilationGermany
-
Federal University of UberlandiaCompletedWeaning Failure | Complication of Respirator [Ventilator]Brazil
-
University Hospital TuebingenNot yet recruitingAcute Respiratory Distress Syndrome
-
Jianfeng XieUnknownMechanical Ventilation | Weaning | Intensive Care MedicineChina
-
The University of Texas Health Science Center,...CompletedRespiratory Distress Syndrome | Apnea of PrematurityUnited States
-
Fundación para la Investigación del Hospital Clínico...Completed
-
Johan Fridolf HermansenCompletedAcute Kidney Injury | Acute Kidney Failure Stage 3Denmark
-
King Fahad Medical CityUnknownBody Temperature Changes | Length of Stay | Pre-Term | Transition | Patient Discharge