Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190346
Status:
TERMINATED
Last Update Posted:
2011-10-26
First Post:
2005-09-13
Brief Title:
Comparison of Humidification Devices During Non Invasive Ventilation in Acute Respiratory Failure
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure
Status:
TERMINATED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of humidification devices during non invasive ventilation in acute respiratory failure
The hypothesis was due to dead space lower humidification a reduced efficiency of the technique NIV when HME are used in comparison with HH
The hypothesis was due to dead space lower humidification a reduced efficiency of the technique NIV when HME are used in comparison with HH
Detailed Description:
Comparison of humidification devices during non invasive ventilation in acute respiratory failure
The hypothesis was due to dead space lower humidification a reduced efficiency of the technique NIV when HME are used in comlparison with HH Several physiological previously performed showed that 1 with HME because of its working principles humidification was reduced because of leaks 2 work of breathing was increased with HME because of dead space and 3 alveolar ventilation was reduced with HME because of additional technical dead space
For these reasons the hypothesis was an improvement of NIV tolerance of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH
The patients were included when requiring NIV see inclusion and exclusion criteria and randomisation was performed with stratification according to presence or absence of respiratory acidosis
The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25 with HME A total of 250 patients was required with alpha risk of 005 and beta risk of 02 power 80 Intubation criteria were predefined according to the litterature The expected duration was 18 months The official support was institutional DRRC of AP-HP HH were furnished free of charge as well as HME Masks used were the same in both groups
The hypothesis was due to dead space lower humidification a reduced efficiency of the technique NIV when HME are used in comlparison with HH Several physiological previously performed showed that 1 with HME because of its working principles humidification was reduced because of leaks 2 work of breathing was increased with HME because of dead space and 3 alveolar ventilation was reduced with HME because of additional technical dead space
For these reasons the hypothesis was an improvement of NIV tolerance of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH
The patients were included when requiring NIV see inclusion and exclusion criteria and randomisation was performed with stratification according to presence or absence of respiratory acidosis
The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25 with HME A total of 250 patients was required with alpha risk of 005 and beta risk of 02 power 80 Intubation criteria were predefined according to the litterature The expected duration was 18 months The official support was institutional DRRC of AP-HP HH were furnished free of charge as well as HME Masks used were the same in both groups
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