Respiratory FailureNCT01994928
Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.
A study testing Nose-mouth mask, High flow nasal cannula oxygen and Intubation in people with Respiratory Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Nose-mouth mask, High flow nasal cannula oxygen and Intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Nov 2014
- 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 treated in an intensive care unit
- indication for intubation
- presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure
- informed consent
Who cannot join
- blocked nasopharynx
- contraindications for nose-mouth mask or high flow nasal cannula oxygen
- expected difficult airway
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
Hamburg, 20246
About this study
Official title: Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.
Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.
- Conditions
- Respiratory Failure
- Being tested
- Nose-mouth mask, High flow nasal cannula oxygen, Intubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nose-mouth maskDevice
Preoxygenation using a nose-mouth mask.
High flow nasal cannula oxygenDevice
Preoxygenation using high flow nasal cannula oxygen.
IntubationProcedure or surgery
Intubation
| Study group | Role | What they receive |
|---|---|---|
| Nose-mouth mask | Active comparator | Performance of intubation after preoxygenation using a nose-mouth mask. Receives: Device: Nose-mouth mask; Procedure: Intubation |
| High flow nasal cannula oxygen | Experimental | Performance of intubation after preoxygenation using high flow nasal cannula oxygen. Receives: Device: High flow nasal cannula oxygen; Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean decrease in the saturation of oxygen (SpO2) during intubation.
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.
Measured: during intubation
Secondary outcomes (1)
Changes in blood gases after intubation.
Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation.
Measured: 30 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994928
- Sponsor's protocol ID
- PV-4429
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2013
- Last updated
- 3 Feb 2021
- Results posted
- No
Publications
Simon M, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.
PubMed 27274092
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.
- ClinicalTrials.gov ID
- NCT01994928
- Acronym / sponsor ID
- PV-4429
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Nov 2013 (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.
Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nose-mouth mask | Active comparator | Device: Nose-mouth mask, Procedure: IntubationPerformance of intubation after preoxygenation using a nose-mouth mask. |
| High flow nasal cannula oxygen | Experimental | Device: High flow nasal cannula oxygen, Procedure: IntubationPerformance of intubation after preoxygenation using high flow nasal cannula oxygen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients treated in an intensive care unit
- indication for intubation
- presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure
- informed consent
Key exclusion criteria (3 listed)
- blocked nasopharynx
- contraindications for nose-mouth mask or high flow nasal cannula oxygen
- expected difficult airway
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 |
|---|---|---|
| Nose-mouth maskPreoxygenation using a nose-mouth mask. | Device | Nose-mouth mask |
| High flow nasal cannula oxygenPreoxygenation using high flow nasal cannula oxygen. | Device | High flow nasal cannula oxygen |
| IntubationIntubation | Procedure or surgery | High flow nasal cannula oxygen, Nose-mouth mask |
Primary outcome
Mean decrease in the saturation of oxygen (SpO2) during intubation.
Time frame: during intubation
Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation.
1 secondary outcome
Changes in blood gases after intubation.
Time frame: 30 minutes after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Results publication: PubMed 27274092Simon M, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nose-mouth mask, High flow nasal cannula oxygen and Intubation in people with Respiratory Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2021. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean decrease in the saturation of oxygen (SpO2) during intubation. (time frame: during intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994928, which also lists 1 linked publication.
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 3 Feb 2021.