Anticipated Difficult AirwayNCT01958346
New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway
A study testing Lingual Traction and Fiberoptic Intubation in people with Anticipated Difficult Airway, run by Enrico Camporesi at 1 site in United States.
Trial summary
We propose the additional technique of lingual traction or "tongue pulling" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticipated Difficult Airway
- What is being tested?
- Lingual Traction and Fiberoptic Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- > 18 years old
- With ASA (American Society of Anesthesiologists) physical status I-III
- With anticipated difficult airway
- Scheduled for elective surgery requiring orotracheal intubation (populations such as elective hip and knee arthroplasty patients)
- Provide written consent
Who cannot join
- With (American Society of Anesthesiologists) ASA physical status IV
- Pregnant
- Require rapid-sequence induction
- Require a non-standard tracheal tub
- Unable to provide written consent
- At risk for pulmonary aspiration of gastric content
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study
We propose the additional technique of lingual traction or "tongue pulling" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.
- Conditions
- Anticipated Difficult Airway
- Being tested
- Lingual Traction, Sham, Fiberoptic Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual TractionOther
The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
ShamOther
Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic IntubationDevice
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic Intubation Alone | Sham comparator | Intubation with fiberoptic scope assistance Receives: Other: Sham; Device: Fiberoptic Intubation |
| Fiberoptic Intubation with lingual traction | Experimental | Intubation with fiberoptic scope assistance and lingual traction maneuver provided by a second anesthesiologist Receives: Other: Lingual Traction; Device: Fiberoptic Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.
Measured: At Intubation
Secondary outcomes (1)
Sore Throat Grade on First Postoperative Day
Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe
Measured: Postoperative day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anticipated Difficult AirwayStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrico Camporesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrico Camporesi, University of South Florida
- Investigators
- Devanand Mangar, MD, Study director, Florida Gulf-to-Bay Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958346
- Sponsor's protocol ID
- Pro00008289
- Status last verified
- Aug 2016
- First submitted
- 4 Oct 2013
- Last updated
- 12 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.
PubMed 15983454Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PubMed 23364566Umesh G, George M, Venkateswaran R. Tongue traction is as effective as jaw lift maneuver for Trachlight-guided orotracheal intubation. Acta Anaesthesiol Taiwan. 2010 Sep;48(3):130-5. doi: 10.1016/S1875-4597(10)60044-6.
PubMed 20864061Rewari V, Ramachandran R, Trikha A. Lingual traction: a useful manoeuvre to lift the epiglottis in a difficult oral fibreoptic intubation. Acta Anaesthesiol Scand. 2009 May;53(5):695-6. doi: 10.1111/j.1399-6576.2009.01934.x. No abstract available.
PubMed 19419380
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01958346
- Acronym / sponsor ID
- Pro00008289
- Conditions
- Anticipated Difficult Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Enrico CamporesiUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 12 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose the additional technique of lingual traction or "tongue pulling" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiberoptic Intubation Alone | Sham comparator | Other: Sham, Device: Fiberoptic IntubationIntubation with fiberoptic scope assistance |
| Fiberoptic Intubation with lingual traction | Experimental | Other: Lingual Traction, Device: Fiberoptic IntubationIntubation with fiberoptic scope assistance and lingual traction maneuver provided by a second anesthesiologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years old
- With ASA (American Society of Anesthesiologists) physical status I-III
- With anticipated difficult airway
- Scheduled for elective surgery requiring orotracheal intubation (populations such as elective hip and knee arthroplasty patients)
- Provide written consent
Key exclusion criteria (6 listed)
- With (American Society of Anesthesiologists) ASA physical status IV
- Pregnant
- Require rapid-sequence induction
- Require a non-standard tracheal tub
- Unable to provide written consent
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 |
|---|---|---|
| Lingual TractionThe tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met. | Other | Fiberoptic Intubation with lingual traction |
| ShamStandard of care fiberoptic intubation without any additional experimental maneuvers | Other | Fiberoptic Intubation Alone |
| Fiberoptic Intubation | Device | Fiberoptic Intubation Alone, Fiberoptic Intubation with lingual traction |
Primary outcome
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.
Time frame: At Intubation
1 secondary outcome
Sore Throat Grade on First Postoperative Day
Time frame: Postoperative day one
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15983454Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.
- Background: PubMed 23364566Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Background: PubMed 20864061Umesh G, George M, Venkateswaran R. Tongue traction is as effective as jaw lift maneuver for Trachlight-guided orotracheal intubation. Acta Anaesthesiol Taiwan. 2010 Sep;48(3):130-5. doi: 10.1016/S1875-4597(10)60044-6.
- Background: PubMed 19419380Rewari V, Ramachandran R, Trikha A. Lingual traction: a useful manoeuvre to lift the epiglottis in a difficult oral fibreoptic intubation. Acta Anaesthesiol Scand. 2009 May;53(5):695-6. doi: 10.1111/j.1399-6576.2009.01934.x. 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.
Devanand Mangar, MD study director
Florida Gulf-to-Bay Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual Traction and Fiberoptic Intubation in people with Anticipated Difficult Airway, run by Enrico Camporesi 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 5 inclusion and 6 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 12 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured. (time frame: At 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 NCT01958346, which also lists 4 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 12 Sep 2016.