AnesthesiaNCT04135651
Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope
A study testing Paratracheal pressure and Cricoid pressure in people with Anesthesia and Intubation; Difficult or Failed, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Anesthesia, Intubation; Difficult or Failed, Cricoid Pressure
- 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
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Dec 2019to 3 Apr 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
- 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 Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope
Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.
Read the detailed description
Primary outcome
- Duration of intubation
Secondary outcomes
- POGO (percentage of glottic opening) score before and after application of each intervention
- Glottic grade by Cormack Lehane
- The success rate in first attempt
- Intubation difficulty scale
- Hemodynamics during intubation
- Postoperative airway complications
- Conditions
- Anesthesia, Intubation; Difficult or Failed, Cricoid Pressure, Pulmonary Aspiration During Anesthetic Induction
- Being tested
- Paratracheal pressure, Cricoid pressure
- Keywords
- Paratracheal pressure, Glottic view, Cricoid pressure, Pentax
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 crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.
| Study group | Role | What they receive |
|---|---|---|
| Paralaryngeal pressure | 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 |
| Cricoid pressure | Active comparator | During the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers. Receives: Procedure: Cricoid pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
The duration from when Pentax pass the tooth to confirm the successful intubation using capnography
Measured: During anesthesia induction procedure
Secondary outcomes (8)
The percentage of glottic opening (POGO) score
The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%
Measured: During anesthesia induction procedure
Cormack-Lehane grade
The grade of glottic opening by intubation device (1= Full view of glottis, easy; 4=Neither glottis nor epiglottis seen, difficult)
Measured: During anesthesia induction procedure
Intubation difficulty scale (IDS)
The intubation difficulty scale by the sum of seven variables (N1-N7). N1= the number of additional intubation attempts, N2= the number of additional operators, N3= the number of alternative intubation techniques used, N4= the laryngoscopic view, as defined by Cormack and Lehane, N5= the lifting force applied during laryngoscopy, N6= to the necessity to apply external laryngeal pressure to optimize glottic exposure, N7= vocal cord mobility. The IDS score is the sum of N1 through N7. The total IDS score ranges from zero (easy) to infinity (difficult).
Measured: During anesthesia induction procedure
Intubation difficulty by NRS score
Intubation difficulty by NRS score (0=easy, 10=the most difficult)
Measured: During anesthesia induction procedure
Success rate in first attempt
Successful intubation in a first attempt
Measured: During anesthesia induction procedure
Hemodynamic changes
Blood pressure (mmHg) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation
Measured: During anesthesia induction procedure
Hemodynamic changes
Heart rate (bpm) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation
Measured: During anesthesia induction procedure
Postoperative complications
Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain
Measured: An average of 1 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start9 Dec 2019
- Primary completion2 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 94 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
- NCT04135651
- Sponsor's protocol ID
- MED-INT-19-340
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 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 Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope
- ClinicalTrials.gov ID
- NCT04135651
- Acronym / sponsor ID
- MED-INT-19-340
- Conditions
- Anesthesia, Intubation; Difficult or Failed, Cricoid Pressure, Pulmonary Aspiration During Anesthetic Induction
- Keywords
- Paratracheal pressure, Glottic view, Cricoid pressure, Pentax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 22 Oct 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.
Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.
Detailed description
Primary outcome
- Duration of intubation
Secondary outcomes
- POGO (percentage of glottic opening) score before and after application of each intervention
- Glottic grade by Cormack Lehane
- The success rate in first attempt
- Intubation difficulty scale
- Hemodynamics during intubation
- Postoperative airway complications
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 |
|---|---|---|
| Paralaryngeal pressure | 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. |
| Cricoid pressure | Active comparator | Procedure: Cricoid pressureDuring the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers. |
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
- 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 | Paralaryngeal pressure |
| Cricoid pressureTo apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies. | Procedure or surgery | Cricoid pressure |
Primary outcome
Time to intubation
Time frame: During anesthesia induction procedure
The duration from when Pentax pass the tooth to confirm the successful intubation using capnography
8 secondary outcomes
The percentage of glottic opening (POGO) score
Time frame: During anesthesia induction procedure
Cormack-Lehane grade
Time frame: During anesthesia induction procedure
Intubation difficulty scale (IDS)
Time frame: During anesthesia induction procedure
Intubation difficulty by NRS score
Time frame: During anesthesia induction procedure
Success rate in first attempt
Time frame: During anesthesia induction procedure
Hemodynamic changes
Time frame: During anesthesia induction procedure
Hemodynamic changes
Time frame: During anesthesia induction procedure
Postoperative complications
Time frame: An average of 1 hours after extubation
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 Anesthesia and Intubation; Difficult or Failed, 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?
Time to intubation (time frame: During anesthesia induction procedure). 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.