Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Medical Center Nijmegen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Medical Center Nijmegen
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01289600
First received: January 27, 2011
Last updated: February 2, 2011
Last verified: February 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2011 | ||||
| Last Updated Date | February 2, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01289600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients | ||||
| Official Title ICMJE | The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS) | ||||
| Brief Summary | The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Acute Respiratory Distress Syndrome | ||||
| Intervention ICMJE | Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01289600 | ||||
| Other Study ID Numbers ICMJE | ARDS1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Leo Heunks, University Medical Center Nijmegen | ||||
| Study Sponsor ICMJE | University Medical Center Nijmegen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Medical Center Nijmegen | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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