IntubationNCT03170037
Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique
A study testing Standard V-E ventilation technique and Reversal V-E ventilation technique in people with Intubation, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Standard V-E ventilation technique and Reversal V-E ventilation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 11 May 2017
- 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
- Over 18 years of age
- Requiring general anesthesia
- BMI =>30
Who cannot join
- Untreated ischemic heart diseases
- Respiratory disorders, including COPD and asthma
- American Society of Anesthesiologists(ASA) physical class of 4 or greater
- Undergoing emergency surgery
- Requiring rapid sequence intubation for aspiration protection
- Non propofol - induction of anesthesia
- Requiring fiberoptic intubation
- Pregnant women or women who have given birth within the last month
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use.
Read the detailed description
Despite advances in intubation technology, difficult airways persist. Because it is failure to oxygenate, not failure to intubate, that ultimately leads to brain injury and cardiovascular collapse, effective mask ventilation is at least as important as successful intubation. Therefore optimizing mask ventilation is crucial for clinicians. When difficult mask ventilation encounters, clinicians often switch to two hand technique to hold the mask including either "C-E" clamp or "V-E" clamp. Both volume mode ventilation and pressure mode ventilation are superior with the V-E technique as compared to the C-E technique. The study will test the hypothesis that a novel reversal V-E mask ventilation technique will retain its high efficiency as that of standard V-E technique but be easier to use than standard V-E technique.
- Conditions
- Intubation
- Being tested
- Standard V-E ventilation technique, Reversal V-E ventilation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard V-E ventilation techniqueProcedure or surgery
For the two-handed standard V-E technique, the facemask is first placed over the bridge of the nose and mouth and then held in place by performing at two-handed jaw thrust maneuver with the index and second finger of each hand and maintaining mask contact with the patient's face by using both thumbs with mouth open. A head-tilt is performed by applying a caudal force on the mandible and mask.
Reversal V-E ventilation techniqueProcedure or surgery
While using reversal V-E technique, the anesthesia provider stands 180 degrees opposite from the head of the bed. Thenar eminence and thumbs secure the mask around the nose while the remaining fingers pull the mandible anteriorly while keeping the mouth open.
| Study group | Role | What they receive |
|---|---|---|
| Standard V-E ventilation technique | Active comparator | After induction of anesthesia subject will be ventilated using the standard V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths. Receives: Procedure: Standard V-E ventilation technique |
| Reversal V-E ventilation technique | Experimental | After induction of anesthesia subject will be ventilated using the reversal V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths. Receives: Procedure: Reversal V-E ventilation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual score of friendliness of mask holding technique using 11 point scale
Visual score of friendliness of mask holding technique using 11 point scale when 0 is easy and 10 is difficult.
Measured: Conclusion of masked ventilation (approximately 5 minutes)
Secondary outcomes (3)
AUC of exhaled tidal volume (Vt) trace
Comparison of AUC of exhaled tidal volume trace
Measured: Period of masked ventilation (approximately 5 minutes)
Vt/AUC
Vt/AUC of exhaled Vt
Measured: Period of masked ventilation (approximately 5 minutes)
Peak inspiratory airway pressure
Peak inspiratory airway pressure
Measured: Period of masked ventilation (approximately 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Apr 2017
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Comparison of 2 two-handed mask ventilation techniques' ease to anesthesia providers
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Canlas, Vanderbilt University Medical Center
- Investigators
- Christopher Canlas, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170037
- Sponsor's protocol ID
- 170299
- Status last verified
- Jul 2017
- First submitted
- 15 May 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique
- ClinicalTrials.gov ID
- NCT03170037
- Acronym / sponsor ID
- 170299
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 30 May 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.
This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use.
Detailed description
Despite advances in intubation technology, difficult airways persist. Because it is failure to oxygenate, not failure to intubate, that ultimately leads to brain injury and cardiovascular collapse, effective mask ventilation is at least as important as successful intubation. Therefore optimizing mask ventilation is crucial for clinicians. When difficult mask ventilation encounters, clinicians often switch to two hand technique to hold the mask including either "C-E" clamp or "V-E" clamp. Both volume mode ventilation and pressure mode ventilation are superior with the V-E technique as compared to the C-E technique. The study will test the hypothesis that a novel reversal V-E mask ventilation technique will retain its high efficiency as that of standard V-E technique but be easier to use than standard V-E technique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of 2 two-handed mask ventilation techniques' ease to anesthesia providers
| Arm | Type | Receives |
|---|---|---|
| Standard V-E ventilation technique | Active comparator | Procedure: Standard V-E ventilation techniqueAfter induction of anesthesia subject will be ventilated using the standard V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths. |
| Reversal V-E ventilation technique | Experimental | Procedure: Reversal V-E ventilation techniqueAfter induction of anesthesia subject will be ventilated using the reversal V-E ventilation technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ratio of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the subjects can be adequately ventilated, as defined by perceivable chest movement and end tidal CO2 during the first three breaths, ventilation will continue for total ten breaths. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Requiring general anesthesia
- BMI =>30
Key exclusion criteria (8 listed)
- Untreated ischemic heart diseases
- Respiratory disorders, including COPD and asthma
- American Society of Anesthesiologists(ASA) physical class of 4 or greater
- Undergoing emergency surgery
- Requiring rapid sequence intubation for aspiration protection
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 |
|---|---|---|
| Standard V-E ventilation techniqueFor the two-handed standard V-E technique, the facemask is first placed over the bridge of the nose and mouth and then held in place by performing at two-handed jaw thrust maneuver with the index and second finger of each hand and maintaining mask contact with the patient's face by using both thumbs with mouth open. A head-tilt is performed by applying a caudal force on the mandible and mask. | Procedure or surgery | Standard V-E ventilation technique |
| Reversal V-E ventilation techniqueWhile using reversal V-E technique, the anesthesia provider stands 180 degrees opposite from the head of the bed. Thenar eminence and thumbs secure the mask around the nose while the remaining fingers pull the mandible anteriorly while keeping the mouth open. | Procedure or surgery | Reversal V-E ventilation technique |
Primary outcome
Visual score of friendliness of mask holding technique using 11 point scale
Time frame: Conclusion of masked ventilation (approximately 5 minutes)
Visual score of friendliness of mask holding technique using 11 point scale when 0 is easy and 10 is difficult.
3 secondary outcomes
AUC of exhaled tidal volume (Vt) trace
Time frame: Period of masked ventilation (approximately 5 minutes)
Vt/AUC
Time frame: Period of masked ventilation (approximately 5 minutes)
Peak inspiratory airway pressure
Time frame: Period of masked ventilation (approximately 5 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 17 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Christopher Canlas, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard V-E ventilation technique and Reversal V-E ventilation technique in people with Intubation, run by Vanderbilt University Medical Center 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 3 inclusion and 8 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 17 Jul 2017. 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?
Visual score of friendliness of mask holding technique using 11 point scale (time frame: Conclusion of masked ventilation (approximately 5 minutes)). 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 17 Jul 2017.