Intubation; DifficultNCT01691703
Combined Technique for Difficult Intubation
A study testing Videolaryngoscope and Bonfils in people with Intubation; Difficult and Failed or Difficult Intubation, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult, Failed or Difficult Intubation, Failed or Difficult Intubation, Initial Encounter
- What is being tested?
- Videolaryngoscope and Bonfils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Feb 2013
- 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
- Informed patient consent Age > 18 years History of difficult intubation (Cormack and Lehane III-IV)
- One or more predictors of a difficult intubation:
- restricted neck movement
- thyromental distance < 60 mm
- interincisor/interdental distance < 30mm
- BMI > 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)
Who cannot join
- No informed patient consent Age < 18 years Emergency surgery, head and/or neck surgery Fasted < 6 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation
A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.
Read the detailed description
In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.
- Conditions
- Intubation; Difficult, Failed or Difficult Intubation, Failed or Difficult Intubation, Initial Encounter, Anesthesia Intubation Complication
- Being tested
- Videolaryngoscope and Bonfils
- Keywords
- Fiber Optic Technology/methods, Intubation, Intratracheal/methods, Laryngoscopy/methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscope and BonfilsDevice
Also called Macintosh videolaryngoscope (Karl Storz), Bonfils® (Karl Storz)
First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope and Bonfils | Experimental | First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position. Receives: Device: Videolaryngoscope and Bonfils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.
The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).
Measured: The patients will be followed during induction of anesthesia, an average of 10 minutes
Secondary outcomes (4)
Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
Measured: The patients will be followed during induction of anesthesia, an average of 10 minutes
Time until successful endotracheal intubation
Time until successful endotracheal intubation will be defined as the time from the moment the blade of the Macintosh videolaryngoscope is placed between the teeth until the time the anaesthesiologist confirms the endotracheal tube to be in the trachea.
Measured: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes
Complications rendered on during the procedure
Complications that will be recorded are: trauma to the oral cavity (defined as any amount of bright red blood in the oral cavity), dental trauma, and regurgitation seen by the anaesthesiologist. Also oxygen saturation (SpO2) at the end of the procedure will be noted, a saturation of less than 90% will be defined as hypoxia.
Measured: The patients will be followed during induction of anesthesia, an average of 10 minutes
Adjuncts being used
Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).
Measured: The patients will be followed during induction of anesthesia, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 Intubation; DifficultStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbe Pieters, Catharina Ziekenhuis Eindhoven
- Investigators
- Barbe MA Pieters, MD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691703
- Sponsor's protocol ID
- COM.12
- Other IDs
- 12-624
- Status last verified
- Feb 2013
- First submitted
- 18 Sep 2012
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.
PubMed 22250284
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation
- ClinicalTrials.gov ID
- NCT01691703
- Acronym / sponsor ID
- COM.12
- Conditions
- Intubation; Difficult, Failed or Difficult Intubation, Failed or Difficult Intubation, Initial Encounter, Anesthesia Intubation Complication
- Keywords
- Fiber Optic Technology/methods, Intubation, Intratracheal/methods, Laryngoscopy/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Sep 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.
A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.
Detailed description
In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope and Bonfils | Experimental | Device: Videolaryngoscope and BonfilsFirst, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed patient consent Age > 18 years History of difficult intubation (Cormack and Lehane III-IV)
- restricted neck movement
- thyromental distance < 60 mm
- interincisor/interdental distance < 30mm
- BMI > 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)
Key exclusion criteria (1 listed)
- No informed patient consent Age < 18 years Emergency surgery, head and/or neck surgery Fasted < 6 hours
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 |
|---|---|---|
| Videolaryngoscope and BonfilsAlso: Macintosh videolaryngoscope (Karl Storz), Bonfils® (Karl Storz)First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position. | Device | Videolaryngoscope and Bonfils |
Primary outcome
Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.
Time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).
4 secondary outcomes
Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
Time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
Time until successful endotracheal intubation
Time frame: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes
Complications rendered on during the procedure
Time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
Adjuncts being used
Time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
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 20 Feb 2013.
- Background: PubMed 22250284Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.
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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.
Barbe MA Pieters, MD principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and Bonfils in people with Intubation; Difficult and Failed or Difficult Intubation, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 6 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: finished, as of the sponsor's last update on 20 Feb 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 Netherlands. 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?
Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone. (time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes). 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 NCT01691703, 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 20 Feb 2013.