NCT00600639|TerminatedPhase 4DMC
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Sponsor study identifier
Secondary identifiers
interventional
82
1 country
1
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years. A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 2007
Actual (reported)December 2007
Actual (reported)January 14, 2008
Actual (reported)January 25, 2008
Actual (reported)Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
3 months
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
3 months
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
standard therapy + oxygen
A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordIstituto Scientifico di Pavia Fondazione Salvatore Maugeri
Pavia, Pavia, 27100, Italy
Stefano Nava
Fondazione Salvatore Maugeri
82 participants (actual enrollment reported by the registry).
First Submitted
January 14, 2008
First Posted
January 25, 2008
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
Timing of Target Enteral Feeding in the Mechanically Ventilated Patient
Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
oxygen plus medical therapy for ARF
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Last Updated
July 17, 2012
Record last verified: 2008-01
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Source: ClinicalTrials.gov.
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