Airway MorbidityNCT02104453
Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person
A study testing airway maneuver in people with Airway Morbidity, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. Sniffing position may improve ventilation between these three maneuvers. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- airway maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to Jul 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients(ASA I-III) scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
Who cannot join
- pneumothorax
- SpO2<96%(without additional oxygen supply)
- vocal cord palsy
- congenital airway abnormality
- facial trauma or deformity
- acute upper airway disease
Show all 14Show fewer
- inadequate fasting time
- neck or potential cervical spine disease
- temporal-mandible joint abnormality
- head and neck tumor
- status post radiotherapy
- pregnancy
- long term sedative or opioid drug use
- patient refuse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Taiwan, 114
Chan, Unervisity, 886-2-87923311 ext. 12963, whcken@gmail.com
Chan, Doctorate
About this study
Official title: Comparative Evaluation of One-handed E-C Clamp Mask Holding Technique, Two-handed Mask Ventilation With Jaw Thrust, and Two-handed Mask Ventilation With Triple Airway Maneuver in the Unconscious Apneic Person
One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. Sniffing position may improve ventilation between these three maneuvers. The investigators hypothesize that ventilation efficiency may be different between these three maneuvers whether the patient is in sniffing position or neutral position. The investigators would like to quantify this effect by measuring the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.
Read the detailed description
Mask ventilation is considered a important skill for airway management during general anesthesia induction and for apneic unconscious patients. One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. However, the efficiency of ventilation between these three maneuvers has to be clarified. Besides, whether sniffing position or neutral position may improve ventilation between these three maneuvers is to be determined. The investigators will collect airway parameters of the patients receiving general anesthesia and measure the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.
- Conditions
- Airway Morbidity
- Being tested
- airway maneuver
- Keywords
- airway maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway maneuverProcedure or surgery
Three-period crossover study: During general anesthesia induction, subjects are assigned to one of the 6 airway maneuver sequences (ABC, CAB, BCA, ACB, CBA, or BAC) in accordance with a randomization schedule. Each maneuver is performed 5 times in a period.
Airway maneuver A: E-C clamp mask holding technique; Airway maneuver B: two-handed mask ventilation with jaw thrust airway maneuver; Airway maneuver C: two-handed mask ventilation with triple airway maneuver(combine jaw thrust and head tilt chin lift)
| Study group | Role | What they receive |
|---|---|---|
| E-C clamp mask holding technique | Experimental | the airway maneuver that press the mask against the patient's face (using the "C" of our thumb and forefinger) while pulling the jaw forward (using the "E" of our other fingers behind the mandible), and leaves one hand free to squeeze the bag. Receives: Procedure: airway maneuver |
| two-handed ventilation with jaw thrust | Experimental | the airway maneuver performed with thumbs point toward feet, palms press down and other fingers perform jaw thrust Receives: Procedure: airway maneuver |
| triple airway maneuver | Experimental | the airway maneuver performed with two-handed mask ventilation, jaw thrust and head-tilt chin-lift technique Receives: Procedure: airway maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air exchange
Expired tidal volume, end tidal CO2 slope, peak inspiratory pressure between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver
Measured: during anesthesia induction
Secondary outcomes (1)
Hemodynamic change
blood pressure and heart rate variability during ventilation between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver
Measured: during anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Hung Chan, Tri-Service General Hospital (TSGH)
- Investigators
- Chan, doctorate, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104453
- Sponsor's protocol ID
- 1-103-05-029
- Other IDs
- WChan
- Status last verified
- Nov 2014
- First submitted
- 28 Mar 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of One-handed E-C Clamp Mask Holding Technique, Two-handed Mask Ventilation With Jaw Thrust, and Two-handed Mask Ventilation With Triple Airway Maneuver in the Unconscious Apneic Person
- ClinicalTrials.gov ID
- NCT02104453
- Acronym / sponsor ID
- 1-103-05-029
- Conditions
- Airway Morbidity
- Keywords
- airway maneuver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 4 Apr 2014 (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.
One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. Sniffing position may improve ventilation between these three maneuvers. The investigators hypothesize that ventilation efficiency may be different between these three maneuvers whether the patient is in sniffing position or neutral position. The investigators would like to quantify this effect by measuring the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.
Detailed description
Mask ventilation is considered a important skill for airway management during general anesthesia induction and for apneic unconscious patients. One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. However, the efficiency of ventilation between these three maneuvers has to be clarified. Besides, whether sniffing position or neutral position may improve ventilation between these three maneuvers is to be determined. The investigators will collect airway parameters of the patients receiving general anesthesia and measure the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-C clamp mask holding technique | Experimental | Procedure: airway maneuverthe airway maneuver that press the mask against the patient's face (using the "C" of our thumb and forefinger) while pulling the jaw forward (using the "E" of our other fingers behind the mandible), and leaves one hand free to squeeze the bag. |
| two-handed ventilation with jaw thrust | Experimental | Procedure: airway maneuverthe airway maneuver performed with thumbs point toward feet, palms press down and other fingers perform jaw thrust |
| triple airway maneuver | Experimental | Procedure: airway maneuverthe airway maneuver performed with two-handed mask ventilation, jaw thrust and head-tilt chin-lift technique |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients(ASA I-III) scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
Key exclusion criteria (14 listed)
- pneumothorax
- SpO2<96%(without additional oxygen supply)
- vocal cord palsy
- congenital airway abnormality
- facial trauma or deformity
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 |
|---|---|---|
| airway maneuverThree-period crossover study: During general anesthesia induction, subjects are assigned to one of the 6 airway maneuver sequences (ABC, CAB, BCA, ACB, CBA, or BAC) in accordance with a randomization schedule. Each maneuver is performed 5 times in a period. Airway maneuver A: E-C clamp mask holding technique; Airway maneuver B: two-handed mask ventilation with jaw thrust airway maneuver; Airway maneuver C: two-handed mask ventilation with triple airway maneuver(combine jaw thrust and head tilt chin lift) | Procedure or surgery | E-C clamp mask holding technique, triple airway maneuver, two-handed ventilation with jaw thrust |
Primary outcome
Air exchange
Time frame: during anesthesia induction
Expired tidal volume, end tidal CO2 slope, peak inspiratory pressure between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver
1 secondary outcome
Hemodynamic change
Time frame: during anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Chan, doctorate principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airway maneuver in people with Airway Morbidity, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 1 inclusion and 14 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 14 Nov 2014. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air exchange (time frame: during anesthesia induction). 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 14 Nov 2014.