NeoplasmsNCT00606788
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
A study testing SmartCare/PS (Automated Weaning) and Conventional weaning in people with Neoplasms and Musculoskeletal Diseases, run by University of Luebeck at 1 site in Germany.
Trial summary
The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms, Musculoskeletal Diseases, Digestive System Diseases
- What is being tested?
- SmartCare/PS (Automated Weaning) and Conventional weaning
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to Feb 2007
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation > 24 hours
- intubation OR tracheostomy
- informed consent
- 35 - 200 kg bodyweight (77,2 - 440,9 lb)
- Ramsay-Score < 3
- spontaneous breathing at a PEEP of < 10 cm H2O
Show all 11Show fewer
- sufficient arterial oxygenation (paO2 > 55 mmHg or SaO2 > 90%)
- haemodynamic stability (< 5 µg/kg/min Dopamine)
- body temperature (rectal) max. 39 °C / 102.2 °F
- hemoglobin > 7 g/dl
- pH > 7,2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.
Read the detailed description
Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. In this context automated computerized systems have become a torchbearer. These systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and ICU length of stay of a given patient in comparison to conventional physician-directed weaning. A multicenter randomized trial by Lellouche et al supported these theories, using a computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now commercially available as SmartCare/PS (Draeger Medical AG \& Co. KG, Luebeck, Germany).
The purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.
- Conditions
- Neoplasms, Musculoskeletal Diseases, Digestive System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases
- Being tested
- SmartCare/PS (Automated Weaning), Conventional weaning
- Keywords
- randomized clinical trials, intensive care, mechanical ventilation, ventilator weaning, clinical protocols, therapy, computer-assisted, humans, various surgical diseases requiring mechanical ventilation over 24 hours
- Medical subject headings
- Neoplasms, Musculoskeletal Diseases, Digestive System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCare/PS (Automated Weaning)Device
Also called SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany)
Patients received computer-driven protocolized weaning
Conventional weaningProcedure or surgery
Patients received physician-directed non-protocolized weaning
| Study group | Role | What they receive |
|---|---|---|
| AW | Active comparator | Patients received computer-driven protocolized weaning (= Automated Weaning) Receives: Device: SmartCare/PS (Automated Weaning) |
| CW | Active comparator | Patients received physician-directed non-protocolized weaning (= Conventional Weaning) Receives: Procedure: Conventional weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning duration
Measured: measured in days
Secondary outcomes (1)
reintubation rate
Measured: expressed as a percentage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startNov 2005
- Primary completionJan 2007 (estimated)
- Study completionFeb 2007 (estimated)
Why it stopped: Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Elke Muhl, Prof. Dr. med., Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606788
- Sponsor's protocol ID
- Luebeck 0001
- Status last verified
- Jan 2008
- First submitted
- 16 Jan 2008
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.
PubMed 16840741
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
- ClinicalTrials.gov ID
- NCT00606788
- Acronym / sponsor ID
- Luebeck 0001
- Conditions
- Neoplasms, Musculoskeletal Diseases, Digestive System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases
- Keywords
- randomized clinical trials, intensive care, mechanical ventilation, ventilator weaning, clinical protocols, therapy, computer-assisted, humans, various surgical diseases requiring mechanical ventilation over 24 hours
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jan 2007 (estimated)
- Study completion
- Feb 2007 (estimated)
- First posted
- 5 Feb 2008 (estimated)
- 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.
The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.
Detailed description
Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. In this context automated computerized systems have become a torchbearer. These systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and ICU length of stay of a given patient in comparison to conventional physician-directed weaning. A multicenter randomized trial by Lellouche et al supported these theories, using a computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now commercially available as SmartCare/PS (Draeger Medical AG \& Co. KG, Luebeck, Germany).
The purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AW | Active comparator | Device: SmartCare/PS (Automated Weaning)Patients received computer-driven protocolized weaning (= Automated Weaning) |
| CW | Active comparator | Procedure: Conventional weaningPatients received physician-directed non-protocolized weaning (= Conventional Weaning) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- mechanical ventilation > 24 hours
- intubation OR tracheostomy
- informed consent
- 35 - 200 kg bodyweight (77,2 - 440,9 lb)
- Ramsay-Score < 3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SmartCare/PS (Automated Weaning)Also: SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany)Patients received computer-driven protocolized weaning | Device | AW |
| Conventional weaningPatients received physician-directed non-protocolized weaning | Procedure or surgery | CW |
Primary outcome
weaning duration
Time frame: measured in days
1 secondary outcome
reintubation rate
Time frame: expressed as a percentage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2008.
- Background: PubMed 16840741Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.
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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.
Elke Muhl, Prof. Dr. med. principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartCare/PS (Automated Weaning) and Conventional weaning in people with Neoplasms and Musculoskeletal Diseases, run by University of Luebeck 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 11 inclusion and 0 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: paused, as of the sponsor's last update on 18 Feb 2008. 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?
Results are not available in the source record.
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 duration (time frame: measured in 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 NCT00606788, which also lists 1 linked publication.
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 18 Feb 2008.