Cardiac ArrestPhase 4LAMETANCT00644722
Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades
A Phase 4 study testing MacIntosh Green Lite (metal single use laryngoscope blades) and MacIntosh Green Spec II (metal reusable laryngoscope blades) in people with Cardiac Arrest and Coma, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Coma, Major Trauma
- What is being tested?
- MacIntosh Green Lite (metal single use laryngoscope blades) and MacIntosh Green Spec II (metal reusable laryngoscope blades)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Jan 2009
- Phase
- Phase 4
- 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
- All adult patients requiring out-of-hospital intubation
Who cannot join
- Patient under 18 years old
- Patients with criteria predictive of impossible intubation under direct laryngoscopy
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP
Créteil, Île-de-France Region, 94010
About this study
Official title: Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties
New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.
Read the detailed description
All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.
Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.
- Conditions
- Cardiac Arrest, Coma, Major Trauma, Respiratory Distress, Shock
- Being tested
- MacIntosh Green Lite (metal single use laryngoscope blades), MacIntosh Green Spec II (metal reusable laryngoscope blades)
- Keywords
- Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency
- Medical subject headings
- Heart Arrest, Coma, Dyspnea, Shock, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacIntosh Green Lite (metal single use laryngoscope blades)Device
Also called Truphatek company -Israel, Smiths Medical France company
metal single use laryngoscope blades
MacIntosh Green Spec II (metal reusable laryngoscope blades)Device
Also called Truphatek company -Israel, Smiths Medical France company
metal reusable laryngoscope blades
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Single use metallic blades Receives: Device: MacIntosh Green Lite (metal single use laryngoscope blades) |
| 2 | Active comparator | Classic reusable metallic blades Receives: Device: MacIntosh Green Spec II (metal reusable laryngoscope blades) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success rate during at the first laryngoscopy
Measured: 10 min
Secondary outcomes (3)
glottis exposure assessed by Cormack and Lehane classification
Measured: 1 day
difficult intubation rate assessed by the Intubation Difficult Score (IDS)
Measured: 1 day
the need for alternative airway techniques and the immediate post intubation complications rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SFMU
- Investigators
- XAVIER COMBES, MD, Principal investigator, Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644722
- Sponsor's protocol ID
- N° 2007-A00350-53
- Acronym
- LAMETA
- Status last verified
- Jan 2009
- First submitted
- 24 Mar 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties
- ClinicalTrials.gov ID
- NCT00644722
- Acronym / sponsor ID
- LAMETA / N° 2007-A00350-53
- Conditions
- Cardiac Arrest, Coma, Major Trauma, Respiratory Distress, Shock
- Keywords
- Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Collaborators
- SFMU
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Mar 2008 (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.
New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.
Detailed description
All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.
Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: MacIntosh Green Lite (metal single use laryngoscope blades)Single use metallic blades |
| 2 | Active comparator | Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)Classic reusable metallic blades |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients requiring out-of-hospital intubation
Key exclusion criteria (2 listed)
- Patient under 18 years old
- Patients with criteria predictive of impossible intubation under direct laryngoscopy
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 |
|---|---|---|
| MacIntosh Green Lite (metal single use laryngoscope blades)Also: Truphatek company -Israel, Smiths Medical France companymetal single use laryngoscope blades | Device | 1 |
| MacIntosh Green Spec II (metal reusable laryngoscope blades)Also: Truphatek company -Israel, Smiths Medical France companymetal reusable laryngoscope blades | Device | 2 |
Primary outcome
Intubation success rate during at the first laryngoscopy
Time frame: 10 min
3 secondary outcomes
glottis exposure assessed by Cormack and Lehane classification
Time frame: 1 day
difficult intubation rate assessed by the Intubation Difficult Score (IDS)
Time frame: 1 day
the need for alternative airway techniques and the immediate post intubation complications rate
Time frame: 1 day
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 29 Jan 2009.
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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.
XAVIER COMBES, MD principal investigator
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MacIntosh Green Lite (metal single use laryngoscope blades) and MacIntosh Green Spec II (metal reusable laryngoscope blades) in people with Cardiac Arrest and Coma, run by Henri Mondor University Hospital 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 2 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 29 Jan 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intubation success rate during at the first laryngoscopy (time frame: 10 min). 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 29 Jan 2009.