Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00221819
• Other study ID #: 9300-02
• Status: Terminated
• Phase: N/A
• First received: September 20, 2005
• Last updated: May 7, 2013
• Start date: June 2004
• Est. completion date: December 2004

Study information

• Verified date: May 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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, P0.1, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Acute Lung Injury
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Lung Injury
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome, Adult

Intervention

Device:
• heated humidifier (device)

• Heat and moisture exchanger (device)

Locations

Country	Name	City	State
France	Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air blood gases at the end of each study period (one with HME, one with HH)
Secondary	Respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation at the end of each study period (one with HME, one with HH)