Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243828
Status:
TERMINATED
Last Update Posted:
2015-09-15
First Post:
2005-10-24
Brief Title:
Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Assessment of the Effectivity of Total-face Mask for Noninvasive Ventilation During Acute Respiratory Failure a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very low rate of recruitment anticipated futility of pursuing the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total-face mask may improve the efficacy of NIV compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaksMAIN OBJECTIVE To assess in acute respiratory failure patients whether the total-face mask reduce the intubation rate METHODS 300 patients admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical ventilation The type of mask total-face vs conventional face mask will be randomized Defined failure criteria and weaning technique will be used
Detailed Description:
HYPOTESIS Total-face mask may improve the efficacy of NIV compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaksOBJECTIVES To assess in acute respiratory failure patients whether the total-face mask reduce the intubation rate Additionally whether it may improve mask tolerance skin pressure damage number of patients receiving higher pressures or even a reduction in mortality METHODS 300 patients admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical ventilation The type of mask total-face vs conventional face mask will be randomized PEEp will be titrated to the best oxygenation and IPAP up to reduce dyspnea and respiratory frequency with the limits at clinical tolerance and massive leaks Defined failure criteria and weaning technique will be used Data to record include clinical parameters and mortality risk score SAPS II and physiologic response to NIV either subjective and objective technique failures and outcome EXPECTED RESULTS The study has been powered to detect a 30 relative improvement in intubation rate from a 35 baseline incidence of intubation in the conventional group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AATRM 151232004 | None | None | None |