Acute Lung InjuryNCT00221819
Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?
A study testing heated humidifier (device) and Heat and moisture exchanger (device) in people with Acute Lung Injury and Pneumonia, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Pneumonia, Chronic Obstructive Pulmonary Disease
- What is being tested?
- heated humidifier (device) and Heat and moisture exchanger (device)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Jun 2004to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,
Bordeaux, 33076
About this study
Official title: Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation
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.
Read the 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, 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.
- Being tested
- heated humidifier (device), Heat and moisture exchanger (device)
- Keywords
- Humidification, Heat and moisture exchanger, Heated humidifier, non invasive ventilation
- Medical subject headings
- Acute Lung Injury, Pneumonia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heated humidifier (device)Device
Heat and moisture exchanger (device)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Air blood gases at the end of each study period (one with HME, one with HH)
Secondary outcomes (1)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- alexandre Boyer, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221819
- Sponsor's protocol ID
- 9300-02
- Status last verified
- May 2013
- First submitted
- 20 Sep 2005
- Last updated
- 9 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation
- ClinicalTrials.gov ID
- NCT00221819
- Acronym / sponsor ID
- 9300-02
- Keywords
- Humidification, Heat and moisture exchanger, Heated humidifier, non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heated humidifier (device) | Device | – |
| Heat and moisture exchanger (device) | Device | – |
Primary outcome
Air blood gases at the end of each study period (one with HME, one with HH)
1 secondary outcome
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)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alexandre Boyer, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heated humidifier (device) and Heat and moisture exchanger (device) in people with Acute Lung Injury and Pneumonia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air blood gases at the end of each study period (one with HME, one with HH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2013.