Chronic Respiratory FailureNCT00415896
Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance
A study testing positive pressure ventilation in people with Chronic Respiratory Failure, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
Trial summary
This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- positive pressure ventilation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypercapnic respiratory failure
Who cannot join
- upper Gi pathology
- renal failure (creatinin > 2 mg/dl)
- Sepsis or infection
- age < 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Kloster Grafschaft
Schmallenberg, Annostr. 1, 57392
Dominic Dellweg, M.D., +49 2972 791 ext. 1257, d.dellweg@fkkg.de
Dieter Koehler, M.D. Prof., +49 2972 791 ext. 2500, d.koehler@fkkg.de
About this study
This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials
Read the detailed description
Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated.
Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial.
References
- Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.
- Conditions
- Chronic Respiratory Failure
- Being tested
- positive pressure ventilation
- Keywords
- weaning, work of breathing, spontaneous breathing trial, rapid shallow breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive pressure ventilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Secondary outcomes (1)
PCO2, respiratory parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies 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
- Crossover
- Masking
- Single blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Investigators
- Dominic Dellweg, M.D., Principal investigator, FKKGDieter Koehler, M.D., Prof., Study chair, FKKG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415896
- Sponsor's protocol ID
- FKKG3
- Status last verified
- Dec 2006
- First submitted
- 22 Dec 2006
- Last updated
- 25 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance
- ClinicalTrials.gov ID
- NCT00415896
- Acronym / sponsor ID
- FKKG3
- Conditions
- Chronic Respiratory Failure
- Keywords
- weaning, work of breathing, spontaneous breathing trial, rapid shallow breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Jun 2007
- First posted
- 25 Dec 2006 (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.
This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials
Detailed description
Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated.
Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial.
References
- Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypercapnic respiratory failure
Key exclusion criteria (4 listed)
- upper Gi pathology
- renal failure (creatinin > 2 mg/dl)
- Sepsis or infection
- age < 18 years
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 |
|---|---|---|
| positive pressure ventilation | Device | – |
Primary outcome
Endurance time
1 secondary outcome
PCO2, respiratory parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2006.
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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.
Dominic Dellweg, M.D. principal investigator
FKKG
Dieter Koehler, M.D., Prof. study chair
FKKG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive pressure ventilation in people with Chronic Respiratory Failure, run by Krankenhaus Kloster Grafschaft 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Dec 2006. 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?
Contact Dominic Dellweg, M.D. (+49 2972 791 ext. 1257, d.dellweg@fkkg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Dec 2006.