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

NCT ID: NCT00221819

Last Updated: 2013-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lung Injury Pneumonia Chronic Obstructive Pulmonary Disease Acute Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

heated humidifier (device)

Intervention Type DEVICE

Heat and moisture exchanger (device)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

alexandre Boyer, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,

Bordeaux, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9300-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HOT HMV 2: A Phase 4 Study
NCT04272879 COMPLETED