Intubation; DifficultCOMBONCT03080896
Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation
A study testing King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III in people with Intubation; Difficult, run by University of Louisville at 1 site in United States.
Trial summary
Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 31 Mar 2024
- 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
- Patient will be eligible for the trial if they:
- Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy or resection requiring intubation of the trachea
- Are 18 years or older
- Sign the approved inform consent
Who cannot join
- Patients will be excluded from the study if:
- Cannot lie down flat without suffering dyspnoea
- Stridor
- Full stomach
- Hiatal hernia
- Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein pump inhibitor and continues to have daily regurgitation
- Require rapid sequence intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine
Louisville, Kentucky, 40202
About this study
Official title: Comparison of Video-Laryngoscope Versus a Combination of a Video-Laryngoscope and Disposable Bronchoscope for Predicted Difficult Airway Intubation of Anesthetized Patients for Oral Cavity, Pharynx or Larynx Surgery
Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of video-laryngoscope with the fiber-optic bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral cavity, pharyngeal or laryngeal pathologies undergoing surgery
Read the detailed description
Detailed Description:
All subjects consented to this study will require endotracheal intubation. They will be randomly assigned to either one of two groups. The randomization will be stratified on whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization groups are:
- Intubation using King Vision video-laryngoscope with the disposable #3 blade and a stylet for placement of the endotracheal tube. This group is considered the "control group".
- Intubation using the King Vision video-laryngoscope with the disposable #3 blade and the fiber-optic bronchoscope (aScope III). This group is considered the "interventional group".
When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable blade and a stylet) the procedure sequence is as follows:
- Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
- Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
- Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard dosing.
- The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
- One anesthesiologist will perform the intubation procedure using the King Vision video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the endotracheal tube (ETT).
- If the anesthesiologist's first attempt to intubate should fail the next attempt will use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and rightward pressure)
- The anesthesiologist may make a total of three attempts to intubate using the control group procedures. Each attempt should be less than 60 seconds and will be aborted if oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between each attempt.
- After three failed attempts to intubate the anesthesiologist will use the interventional group method. Two anesthesiologists will be required to perform the intubation using the King Vision video-laryngoscope with a #3 disposable blade and the video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope will be used to guide the endotracheal tube (ETT).
- The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
- Should the first attempt using the interventional method fail the next attempt will use the standard Storz video-laryngoscope and #4 reusable blade along with the video bronchoscope (aScope III)
- There may be three attempts using the interventional method. Each attempt should be less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should be aborted. The patient will be pre-oxygenated by mask between each attempt.
- After three unsuccessful attempts the patient will be awaken and an "awake" intubation procedure will take place.
- The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
- Study ends once the patient is intubated and breath sounds confirmed or when it is decided an "awake" intubation is needed.
When randomized to the "interventional" group. (King Vision video-laryngoscope and #3 disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:
- Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
- Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
- Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg)This is standard dosing.
- The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
- Two anesthesiologist will perform the procedure
- The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
- Should the first attempt fail to intubate the patient the next attempt will use the Storz video- laryngoscope with a #4 reusable blade with the video-bronchoscope (aScope III)
- A total of three attempts may be made using the interventional method. Each attempt should be less than 60 seconds and aborted if the oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask with 100% oxygen between each attempt.
- If failure to intubate should occur the patient will be awaken and an "awake" intubation will be performed.
- The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
- The study will end with successful intubation and confirmation of breath sounds or when it is determined an "awake" intubation is necessary.
- Conditions
- Intubation; Difficult
- Being tested
- King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet, fiberoptic bronchoscope aScope III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision video-laryngoscope with #3 disposable blade and endotracheal tube styletDevice
Also called Ambu aScope III
intubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts
fiberoptic bronchoscope aScope IIIDevice
Also called aScope III by Ambu
Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)
| Study group | Role | What they receive |
|---|---|---|
| control group videolaryngoscope/preformed stylet | Active comparator | The control group will intubate using the video-laryngoscope / pre formed stylet. Will convert to using video-laryngoscope and fiber-optic bronchoscope (aScope III) if failure to intubate occurs Receives: Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet; Device: fiberoptic bronchoscope aScope III |
| Interventional Group videolaryngoscope/fibeoptic bronch | Experimental | The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III) Receives: Device: fiberoptic bronchoscope aScope III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful intubation
measured in seconds
Measured: From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes
Secondary outcomes (2)
Conversion from control group to intervention group
Number of subjects randomized to control group who require to be treated with the method of the intervention group
Measured: From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes
Number of intubation attempts until successful
whole numbers of attempts
Measured: From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start10 Apr 2017
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Principal investigator, Rainer Lenhardt, University of Louisville
- Investigators
- Rainer Lenhardt, MD MBA, Principal investigator, University of Louisville 530 South Jackson Street Louisville, KY 40202
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080896
- Sponsor's protocol ID
- IRB #15.0096
- Acronym
- COMBO
- Status last verified
- May 2024
- First submitted
- 27 Jan 2017
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: individual patients data will not be shared. Results or the studies findings will be published
Publications
Juneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32.
Stacey M, Rassam S, Sivasankar R, Hall J. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: more solutions. Br J Anaesth. 2005 Jul;95(1):112. doi: 10.1093/bja/aei570. No abstract available.
PubMed 15941739Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.
PubMed 12826557Doyle DJ. GlideScope-assisted fiberoptic intubation: a new airway teaching method. Anesthesiology. 2004 Nov;101(5):1252. doi: 10.1097/00000542-200411000-00046. No abstract available.
PubMed 15505482Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.
PubMed 17975233Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a.
PubMed 19923515Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041.
PubMed 8467551Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PubMed 6507827Janda M, Scheeren TW, Noldge-Schomburg GF. Management of pulmonary aspiration. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):409-27. doi: 10.1016/j.bpa.2006.02.006.
PubMed 17080693Fasting S, Gisvold SE. Serious intraoperative problems--a five-year review of 83,844 anesthetics. Can J Anaesth. 2002 Jun-Jul;49(6):545-53. doi: 10.1007/BF03017379.
PubMed 12067864Siu LW, Mathieson E, Naik VN, Chandra D, Joo HS. Patient- and operator-related factors associated with successful Glidescope intubations: a prospective observational study in 742 patients. Anaesth Intensive Care. 2010 Jan;38(1):70-5. doi: 10.1177/0310057X1003800113.
PubMed 20191780Van Zundert AA, Hermans B, Kuczkowski KM. Successful use of a videolaryngoscope in a patient with carcinoma of the oropharynx and obstructed airway. Minerva Anestesiol. 2009 Jul-Aug;75(7-8):475-6. No abstract available.
PubMed 19571781Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.
PubMed 24842175
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video-Laryngoscope Versus a Combination of a Video-Laryngoscope and Disposable Bronchoscope for Predicted Difficult Airway Intubation of Anesthetized Patients for Oral Cavity, Pharynx or Larynx Surgery
- ClinicalTrials.gov ID
- NCT03080896
- Acronym / sponsor ID
- COMBO / IRB #15.0096
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of video-laryngoscope with the fiber-optic bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral cavity, pharyngeal or laryngeal pathologies undergoing surgery
Detailed description
Detailed Description:
All subjects consented to this study will require endotracheal intubation. They will be randomly assigned to either one of two groups. The randomization will be stratified on whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization groups are:
- Intubation using King Vision video-laryngoscope with the disposable #3 blade and a stylet for placement of the endotracheal tube. This group is considered the "control group".
- Intubation using the King Vision video-laryngoscope with the disposable #3 blade and the fiber-optic bronchoscope (aScope III). This group is considered the "interventional group".
When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable blade and a stylet) the procedure sequence is as follows:
- Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
- Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
- Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard dosing.
- The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
- One anesthesiologist will perform the intubation procedure using the King Vision video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the endotracheal tube (ETT).
- If the anesthesiologist's first attempt to intubate should fail the next attempt will use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and rightward pressure)
- The anesthesiologist may make a total of three attempts to intubate using the control group procedures. Each attempt should be less than 60 seconds and will be aborted if oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between each attempt.
- After three failed attempts to intubate the anesthesiologist will use the interventional group method. Two anesthesiologists will be required to perform the intubation using the King Vision video-laryngoscope with a #3 disposable blade and the video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope will be used to guide the endotracheal tube (ETT).
- The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
- Should the first attempt using the interventional method fail the next attempt will use the standard Storz video-laryngoscope and #4 reusable blade along with the video bronchoscope (aScope III)
- There may be three attempts using the interventional method. Each attempt should be less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should be aborted. The patient will be pre-oxygenated by mask between each attempt.
- After three unsuccessful attempts the patient will be awaken and an "awake" intubation procedure will take place.
- The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
- Study ends once the patient is intubated and breath sounds confirmed or when it is decided an "awake" intubation is needed.
When randomized to the "interventional" group. (King Vision video-laryngoscope and #3 disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:
- Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
- Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
- Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg)This is standard dosing.
- The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
- Two anesthesiologist will perform the procedure
- The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
- Should the first attempt fail to intubate the patient the next attempt will use the Storz video- laryngoscope with a #4 reusable blade with the video-bronchoscope (aScope III)
- A total of three attempts may be made using the interventional method. Each attempt should be less than 60 seconds and aborted if the oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask with 100% oxygen between each attempt.
- If failure to intubate should occur the patient will be awaken and an "awake" intubation will be performed.
- The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
- The study will end with successful intubation and confirmation of breath sounds or when it is determined an "awake" intubation is necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group videolaryngoscope/preformed stylet | Active comparator | Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet, Device: fiberoptic bronchoscope aScope IIIThe control group will intubate using the video-laryngoscope / pre formed stylet. Will convert to using video-laryngoscope and fiber-optic bronchoscope (aScope III) if failure to intubate occurs |
| Interventional Group videolaryngoscope/fibeoptic bronch | Experimental | Device: fiberoptic bronchoscope aScope IIIThe interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient will be eligible for the trial if they:
Key exclusion criteria (7 listed)
- Patients will be excluded from the study if:
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 |
|---|---|---|
| King Vision video-laryngoscope with #3 disposable blade and endotracheal tube styletAlso: Ambu aScope IIIintubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts | Device | control group videolaryngoscope/preformed stylet |
| fiberoptic bronchoscope aScope IIIAlso: aScope III by AmbuIntubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III) | Device | Interventional Group videolaryngoscope/fibeoptic bronch, control group videolaryngoscope/preformed stylet |
Primary outcome
Time to successful intubation
Time frame: From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes
measured in seconds
2 secondary outcomes
Conversion from control group to intervention group
Time frame: From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes
Number of intubation attempts until successful
Time frame: From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten 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 28 May 2024.
- BackgroundJuneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32.
- Background: PubMed 15941739Stacey M, Rassam S, Sivasankar R, Hall J. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: more solutions. Br J Anaesth. 2005 Jul;95(1):112. doi: 10.1093/bja/aei570. No abstract available.
- Background: PubMed 12826557Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.
- Background: PubMed 15505482Doyle DJ. GlideScope-assisted fiberoptic intubation: a new airway teaching method. Anesthesiology. 2004 Nov;101(5):1252. doi: 10.1097/00000542-200411000-00046. No abstract available.
- Background: PubMed 17975233Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.
- Background: PubMed 19923515Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a.
- Background: PubMed 8467551Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041.
- Background: PubMed 6507827Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Background: PubMed 17080693Janda M, Scheeren TW, Noldge-Schomburg GF. Management of pulmonary aspiration. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):409-27. doi: 10.1016/j.bpa.2006.02.006.
- Background: PubMed 12067864Fasting S, Gisvold SE. Serious intraoperative problems--a five-year review of 83,844 anesthetics. Can J Anaesth. 2002 Jun-Jul;49(6):545-53. doi: 10.1007/BF03017379.
- Results publication: PubMed 20191780Siu LW, Mathieson E, Naik VN, Chandra D, Joo HS. Patient- and operator-related factors associated with successful Glidescope intubations: a prospective observational study in 742 patients. Anaesth Intensive Care. 2010 Jan;38(1):70-5. doi: 10.1177/0310057X1003800113.
- Results publication: PubMed 19571781Van Zundert AA, Hermans B, Kuczkowski KM. Successful use of a videolaryngoscope in a patient with carcinoma of the oropharynx and obstructed airway. Minerva Anestesiol. 2009 Jul-Aug;75(7-8):475-6. No abstract available.
- Individual participant dataSharing planned: Undecided. individual patients data will not be shared. Results or the studies findings will be published
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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.
Rainer Lenhardt, MD MBA principal investigator
University of Louisville 530 South Jackson Street Louisville, KY 40202
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III in people with Intubation; Difficult, run by University of Louisville at 1 site in United States.
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 7 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 28 May 2024. 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 United States. 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?
Time to successful intubation (time frame: From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten 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 NCT03080896, which also lists 13 linked publications.
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 28 May 2024.