Neurologic DisorderNCT05483244
Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
An observational study of Neurologic Disorder and Respiratory Insufficiency, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurologic Disorder, Respiratory Insufficiency
- What is being tested?
- discontinuous weaning and continuous weaning
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with neurological main diagnoses, who admitted to early neurological rehabilitation and are under mechanical ventilation.
Who may be able to join
- mechanical ventilation at admission to neurological rehabilitation
- weaned by a continuous or discontinuous weaning strategy
Who cannot join
- pre-existing mechanical ventilation before disease onset
- mixed weaning strategies (continuous and discontinuous) during weaning process
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
Hessisch Oldendorf, Lower Saxony, 31840
About this study
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.
Read the 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.
- Conditions
- Neurologic Disorder, Respiratory Insufficiency
- Being tested
- discontinuous weaning, continuous weaning
- Keywords
- early neurological rehabilitation, weaning strategy, weaning success
- Medical subject headings
- Nervous System Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinuous weaningOther
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 weaningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: discontinuous weaning | |
| 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. Receives: Other: continuous weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success
number of patients who could weaned sucessfully from mechanical ventilation
Measured: through study completion, an average of 70 days
Secondary outcomes (1)
weaning duration
duration of mechnaical ventilation (in hours)
Measured: through study completion, an average of 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start20 Nov 2021
- Primary completion28 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone B Schmidt, Dr., Principal investigator, BDH-Klinik Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483244
- Sponsor's protocol ID
- Weaning Strategy
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 7823995Teismann 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.
PubMed 25871403Vitacca 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.
PubMed 11463592Matic 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.
PubMed 17309139
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
- ClinicalTrials.gov ID
- NCT05483244
- Acronym / sponsor ID
- Weaning Strategy
- Conditions
- Neurologic Disorder, Respiratory Insufficiency
- Keywords
- early neurological rehabilitation, weaning strategy, weaning success
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| discontinuous weaning group | – | Other: discontinuous weaningPatients 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. |
| continuous weaning group | – | Other: continuous weaningIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with neurological main diagnoses, who admitted to early neurological rehabilitation and are under mechanical ventilation.
Key inclusion criteria (2 listed)
- mechanical ventilation at admission to neurological rehabilitation
- weaned by a continuous or discontinuous weaning strategy
Key exclusion criteria (2 listed)
- pre-existing mechanical ventilation before disease onset
- mixed weaning strategies (continuous and discontinuous) during weaning process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discontinuous weaningEach 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. | Other | discontinuous weaning group |
| continuous weaningEach 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. | Other | continuous weaning group |
Primary outcome
weaning success
Time frame: through study completion, an average of 70 days
number of patients who could weaned sucessfully from mechanical ventilation
1 secondary outcome
weaning duration
Time frame: through study completion, an average of 70 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 7823995Esteban 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.
- Background: PubMed 25871403Teismann 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.
- Background: PubMed 11463592Vitacca 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.
- Background: PubMed 17309139Matic 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.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone B Schmidt, Dr. principal investigator
BDH-Klinik Hessisch Oldendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Respiratory Insufficiency, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success (time frame: through study completion, an average of 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.