Viewing Study NCT00221819



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Study NCT ID: NCT00221819
Status: TERMINATED
Last Update Posted: 2013-05-09
First Post: 2005-09-20

Brief Title: Gases Humidification During Noninvasive Ventilation Heat and Moisture Exchanger or Heated Humidifier
Sponsor: University Hospital Bordeaux
Organization: University Hospital Bordeaux

Study Overview

Official Title: Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation
Status: TERMINATED
Status Verified Date: 2013-05
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: To humidify gases during non invasive ventilation both to heated humidifier HH and heat and moisture exchanger HME are routinely used Patients receiving non invasive ventilation for acute respiratory failure were randomized to HME or HH The purpose of this study was to evaluate respiratory parameters and arterial blood gases ABG of patients during NIV with small dead space HME compared to HH
Detailed Description: Objective Few data are reported in the field of noninvasive ventilation NIV regarding humidification devices It was previously suggested that standard heat and moisture exchangers HME had adverse gasometrical and clinical outcomes in acute respiratory failure ARF of chronic respiratory failure patients CRF This study was performed to evaluate respiratory parameters and arterial blood gases ABG of patients during NIV with small dead space HME compared to heated humidifier HH

Design Prospective randomized cross-over study Setting A 16-bed medical intensive care unit ICU and a 14-bed medico surgical ICU

Patients Patients receiving NIV for ARF in the context of CRF or hypoxic ARF and patients with persistent weaning failure receiving NIV just after extubation

Measurements HME and HH were randomly compared during 2 NIV periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen ABG were collected at baseline and at the end of each period As well as respiratory parameters including volumes pressures P01 a comfort score capnometry and oxygen saturation Two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not

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