Contamination of the HandlesMUURNCT01632085
Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R)
A study testing The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device. in people with Contamination of the Handles and Quality of the Laryngoscopy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contamination of the Handles, Quality of the Laryngoscopy
- What is being tested?
- The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jun 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
- Men or women over 18 years·
- Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
- Subject has signed informed consent·
- Suject affiliated to a social protection·
- Subject informed of the results of medical examination
Who cannot join
- Contraindication to general anesthesia or one of its components·
- General anesthesia without a competitive muscle relaxant·
- Patient with criteria for difficult intubation·
- Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
- Subject in class 4 Mallampati·
- Acts performed in the emergency setting·
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- Pregnancy and obstetric procedures·
- Breastfeeding·
- Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
- Subject in exclusion period (determined by a previous study or a study in progress)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67098
Simone MANGEANT, MD
Nadia DHIF, MD
About this study
Official title: Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle
Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.
- Being tested
- The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.Device
Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®.
Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R.
| Study group | Role | What they receive |
|---|---|---|
| Group SU (Single use or Laryngobloc ®) ®) | Other | In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Laryngobloc ®. Receives: Device: The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device. |
| Group R (Reusable handle) | Other | In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Disposable Metal Blade. Receives: Device: The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of laryngoscopy
The quality of laryngoscopy. The quality of the visibility of the glottis, is assessed by the Cormack and Lehane grade. A rank of 1 or 2 will be considered a success for the analysis of results.
Measured: 1 year
Secondary outcomes (1)
Evaluation microbiological and evaluation of intubation
Evaluation microbiological (bacteria, fungi) and identification of bacteria with smears of the handle of laryngoscopes, the Laryngobloc ® and the reusable battery.
Evaluation of intubation: IDS score, satisfaction of the anesthesiologist, intubation time, quality of light offered by the device.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contamination of the HandlesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632085
- Sponsor's protocol ID
- 5131
- Other IDs
- 2011-A01548-33
- Acronym
- MUUR
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle
- ClinicalTrials.gov ID
- NCT01632085
- Acronym / sponsor ID
- MUUR / 5131
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 29 Jun 2012 (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.
Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SU (Single use or Laryngobloc ®) ®) | Other | Device: The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Laryngobloc ®. |
| Group R (Reusable handle) | Other | Device: The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Disposable Metal Blade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women over 18 years·
- Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
- Subject has signed informed consent·
- Suject affiliated to a social protection·
- Subject informed of the results of medical examination
Key exclusion criteria (10 listed)
- Contraindication to general anesthesia or one of its components·
- General anesthesia without a competitive muscle relaxant·
- Patient with criteria for difficult intubation·
- Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
- Subject in class 4 Mallampati·
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 |
|---|---|---|
| The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®. Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R. | Device | Group R (Reusable handle), Group SU (Single use or Laryngobloc ®) ®) |
Primary outcome
The quality of laryngoscopy
Time frame: 1 year
The quality of laryngoscopy. The quality of the visibility of the glottis, is assessed by the Cormack and Lehane grade. A rank of 1 or 2 will be considered a success for the analysis of results.
1 secondary outcome
Evaluation microbiological and evaluation of intubation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device. in people with Contamination of the Handles and Quality of the Laryngoscopy, run by University Hospital, Strasbourg, France 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre DIEMUNSCH, Pr (03 88 12 70 76, pierre.diemunsch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of laryngoscopy (time frame: 1 year). 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 Jun 2012.