General AnesthesiaNCT04106635
Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway
A study testing Paratracheal pressure and Cricoid pressure in people with General Anesthesia and Pulmonary Aspiration, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- General Anesthesia, Pulmonary Aspiration
- What is being tested?
- Paratracheal pressure and Cricoid pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2020to 17 Jul 2020
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
- American Society of Anesthesiologists Classification 1-2
Who cannot join
- Body mass index > 35 kg/m2
- High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway
Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice.
On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation.
Read more
Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.
In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.
- Conditions
- General Anesthesia, Pulmonary Aspiration
- Being tested
- Paratracheal pressure, Cricoid pressure
- Keywords
- Laryngeal mask airway, Paratracheal esophageal pressure, Cricoid pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paratracheal pressureProcedure or surgery
To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.
Cricoid pressureProcedure or surgery
To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.
| Study group | Role | What they receive |
|---|---|---|
| PP group | Experimental | During the induction of anesthesia, left paratracheal pressure is applied by 30N force with thumb after confirmation of the location of the esophagus using ultrasound. Receives: Procedure: Paratracheal pressure |
| CP group | Active comparator | During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger. Receives: Procedure: Cricoid pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of device insertion
Successful insertion of laryngeal mask airway in a maximum of three attempts
Measured: During induction of anesthesia, an average of 60 seconds
Secondary outcomes (9)
The grade of fiberoptic bronchoscopic view
The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: < 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: > 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.
Measured: During induction of anesthesia, an average of 5 minutes
The time for successful insertion of the device
The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.
Measured: : During induction of anesthesia, an average of 60 seconds
Peak inspiratory pressure
Peak inspiratory pressure is recorded from mechanical ventilator.
Measured: At 5 minute after insertion of laryngeal mask airway
The ease of insertion of device
The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device
Measured: During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device
The number of attempts for successful insertion of laryngeal mask airway
Measured: During induction of anesthesia, an average of 60 seconds
Success rate in first attempt
Successful insertion of laryngeal mask airway in a first attempt
Measured: : During induction of anesthesia, an average of 60 seconds
Incidence of intraoperative complications
Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.
Measured: During the surgery, an average of 2 hours after anesthesia induction
Incidence of postoperative complications
Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.
Measured: An average of 2 hours after extubation
The presence of gastric air insufflation after induction of anesthesia
The presence of gastric air insufflation is defined as an increase in antral cross-sectional area and/or presence of air artifacts in the antrum (comet tail, posterior acoustic shadow) confirmed by ultrasound.
Measured: During induction of anesthesia, an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Jan 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106635
- Sponsor's protocol ID
- MED-INT-19-361
- Status last verified
- Jan 2021
- First submitted
- 25 Sep 2019
- Last updated
- 13 Jan 2021
- 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 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT04106635
- Acronym / sponsor ID
- MED-INT-19-361
- Conditions
- General Anesthesia, Pulmonary Aspiration
- Keywords
- Laryngeal mask airway, Paratracheal esophageal pressure, Cricoid pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 27 Sep 2019 (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.
Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice.
On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation.
Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.
In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| PP group | Experimental | Procedure: Paratracheal pressureDuring the induction of anesthesia, left paratracheal pressure is applied by 30N force with thumb after confirmation of the location of the esophagus using ultrasound. |
| CP group | Active comparator | Procedure: Cricoid pressureDuring the induction of anesthesia, cricoid pressure is applied by 30N force with three finger. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
- American Society of Anesthesiologists Classification 1-2
Key exclusion criteria (3 listed)
- Body mass index > 35 kg/m2
- High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),
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 |
|---|---|---|
| Paratracheal pressureTo apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle. | Procedure or surgery | PP group |
| Cricoid pressureTo apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies. | Procedure or surgery | CP group |
Primary outcome
The success rate of device insertion
Time frame: During induction of anesthesia, an average of 60 seconds
Successful insertion of laryngeal mask airway in a maximum of three attempts
9 secondary outcomes
The grade of fiberoptic bronchoscopic view
Time frame: During induction of anesthesia, an average of 5 minutes
The time for successful insertion of the device
Time frame: : During induction of anesthesia, an average of 60 seconds
Peak inspiratory pressure
Time frame: At 5 minute after insertion of laryngeal mask airway
The ease of insertion of device
Time frame: During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device
Time frame: During induction of anesthesia, an average of 60 seconds
Success rate in first attempt
Time frame: : During induction of anesthesia, an average of 60 seconds
Incidence of intraoperative complications
Time frame: During the surgery, an average of 2 hours after anesthesia induction
Incidence of postoperative complications
Time frame: An average of 2 hours after extubation
The presence of gastric air insufflation after induction of anesthesia
Time frame: During induction of anesthesia, an average of 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 13 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paratracheal pressure and Cricoid pressure in people with General Anesthesia and Pulmonary Aspiration, run by Ajou University School of Medicine at 1 site in South Korea.
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 2 inclusion and 3 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 13 Jan 2021. 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 South Korea. 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?
The success rate of device insertion (time frame: During induction of anesthesia, an average of 60 seconds). 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 13 Jan 2021.