Endotracheal IntubationNCT03990337
Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure
A study testing Ultrasound in people with Endotracheal Intubation and General Anesthesia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, General Anesthesia
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2018to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years,
- ASA physical status I and II,
- body mass index <28 kg/m2,
- scheduled to undergo surgical procedures requiring general anesthesia and endotracheal intubation.
Who cannot join
- cardiac diseases,
- respiratory diseases,
- liver diseases,
- gastroesophageal reflux symptoms,
- anticipated difficult airway and/or anticipated difficult bag-mask ventilation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Fabricio Zasso, MD
Naveed Siddiqui, MD
About this study
Official title: Impact of Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure
This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Based on the potential results that may show that US could be a tool for improve the effectiveness of cricoid pressure, the investigators expect to disseminate this knowledge to be transformed in the standard technique for helping anesthesiologists and nurses to do pressure in the correct location. It is expected that the greatest impact of this study will lead to improved patient outcomes and safety, particularly in the ones with high-risk for aspiration.
Read the detailed description
This is a prospective two-arm randomized controlled single blinded study to be conducted at Mount Sinai Hospital, University of Toronto. The study will be conducted in the operating rooms (OR) with patients as subjects, and OR nurses and scheduled anesthesiologists as participants.Following signed informed consent, patients will be randomized into two groups:(i) Control group (CPG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography and (ii) Ultrasound group (USG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with US. The oesophagus of the patient participants in both groups will also be identified by US. A portable US machine will be present in the operating room for all patients in both groups.
The anesthesiologist scheduled for the surgery is blinded to group allocation and will induce the patient with general anesthesia. The anesthesiologist will provide adequate oxygenation with 100% oxygen to reach an end-tidal oxygen ≥ 90% using mask ventilation. Thereafter, the scheduled anesthesiologist will step out of the operating room. Apneic oxygenation will be maintained using a nasal cannula with 100% oxygen at 5 litres/min. During apneic oxygenation, one of the research anesthesiologists will localize the cricoid cartilage using US (for patients in USG group). Prior to applying cricoid pressure, the nurse will be instructed to use an estimated pressure (of 30 Newtons) that causes discomfort when applied to his/her nasal bridge. The nurse will then apply an estimated 30 Newtons pressure on the cricoid cartilage localized by US for patients in the USG group or blindly without US for patients in CPG group.
The anesthesiologist will then return to the operating room and perform a videolaryngoscopy to directly visualize up to three attempts to pass a lubricated 20F gastric tube at the upper outlet of the esophagus with (i) pressure directly on the cricoid cartilage and (ii) with pressure on the cricoid cartilage shifted to the left and right of the midline. Following removal of the gastric tube and videolaryngoscope, the trachea will be intubated using direct laryngoscopy with a McIntosh blade. Cricoid pressure will be released after the cuff of the endotracheal tube is inflated. Thereafter, the location of the CC (blindly without US) for patients in CPG group will be marked and compared to the location that will be identified with US.
- Conditions
- Endotracheal Intubation, General Anesthesia
- Being tested
- Ultrasound
- Keywords
- Ultrasound, Cricoid Cartilage, Cricoid Pressure, General Anesthesia, Endotracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasonography of cricoid cartilage.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CPG, n=65) | No intervention | cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography |
| Ultrasound group (USG, n=65) | Active comparator | cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with ultrasonography Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cricoid pressure effectiveness
Cricoid pressure effectiveness defined as the failure to pass the gastric tube after 3 attempts
Measured: 5 minutes
Secondary outcomes (2)
Cormack-Lehane classification
Cormack-Lehane classification for direct laryngoscopy
Measured: 5 minutes
Cricoid pressure release
necessity of cricoid pressure release for intubation.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start30 Jul 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective two-arm randomized controlled single blinded
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric You-Ten, Mount Sinai Hospital, Canada
- Investigators
- Kong Eric You-Ten, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990337
- Sponsor's protocol ID
- 17-0271-A
- Status last verified
- Jun 2019
- First submitted
- 30 Jul 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure
- ClinicalTrials.gov ID
- NCT03990337
- Acronym / sponsor ID
- 17-0271-A
- Conditions
- Endotracheal Intubation, General Anesthesia
- Keywords
- Ultrasound, Cricoid Cartilage, Cricoid Pressure, General Anesthesia, Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Jun 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.
This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Based on the potential results that may show that US could be a tool for improve the effectiveness of cricoid pressure, the investigators expect to disseminate this knowledge to be transformed in the standard technique for helping anesthesiologists and nurses to do pressure in the correct location. It is expected that the greatest impact of this study will lead to improved patient outcomes and safety, particularly in the ones with high-risk for aspiration.
Detailed description
This is a prospective two-arm randomized controlled single blinded study to be conducted at Mount Sinai Hospital, University of Toronto. The study will be conducted in the operating rooms (OR) with patients as subjects, and OR nurses and scheduled anesthesiologists as participants.Following signed informed consent, patients will be randomized into two groups:(i) Control group (CPG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography and (ii) Ultrasound group (USG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with US. The oesophagus of the patient participants in both groups will also be identified by US. A portable US machine will be present in the operating room for all patients in both groups.
The anesthesiologist scheduled for the surgery is blinded to group allocation and will induce the patient with general anesthesia. The anesthesiologist will provide adequate oxygenation with 100% oxygen to reach an end-tidal oxygen ≥ 90% using mask ventilation. Thereafter, the scheduled anesthesiologist will step out of the operating room. Apneic oxygenation will be maintained using a nasal cannula with 100% oxygen at 5 litres/min. During apneic oxygenation, one of the research anesthesiologists will localize the cricoid cartilage using US (for patients in USG group). Prior to applying cricoid pressure, the nurse will be instructed to use an estimated pressure (of 30 Newtons) that causes discomfort when applied to his/her nasal bridge. The nurse will then apply an estimated 30 Newtons pressure on the cricoid cartilage localized by US for patients in the USG group or blindly without US for patients in CPG group.
The anesthesiologist will then return to the operating room and perform a videolaryngoscopy to directly visualize up to three attempts to pass a lubricated 20F gastric tube at the upper outlet of the esophagus with (i) pressure directly on the cricoid cartilage and (ii) with pressure on the cricoid cartilage shifted to the left and right of the midline. Following removal of the gastric tube and videolaryngoscope, the trachea will be intubated using direct laryngoscopy with a McIntosh blade. Cricoid pressure will be released after the cuff of the endotracheal tube is inflated. Thereafter, the location of the CC (blindly without US) for patients in CPG group will be marked and compared to the location that will be identified with US.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- prospective two-arm randomized controlled single blinded
| Arm | Type | Receives |
|---|---|---|
| Control group (CPG, n=65) | No intervention | –cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography |
| Ultrasound group (USG, n=65) | Active comparator | Device: Ultrasoundcricoid pressure applied by the OR nurse on the cricoid cartilage after localization with ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years,
- ASA physical status I and II,
- body mass index <28 kg/m2,
- scheduled to undergo surgical procedures requiring general anesthesia and endotracheal intubation.
Key exclusion criteria (5 listed)
- cardiac diseases,
- respiratory diseases,
- liver diseases,
- gastroesophageal reflux symptoms,
- anticipated difficult airway and/or anticipated difficult bag-mask ventilation
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 |
|---|---|---|
| UltrasoundUltrasonography of cricoid cartilage. | Device | Ultrasound group (USG, n=65) |
Primary outcome
Cricoid pressure effectiveness
Time frame: 5 minutes
Cricoid pressure effectiveness defined as the failure to pass the gastric tube after 3 attempts
2 secondary outcomes
Cormack-Lehane classification
Time frame: 5 minutes
Cricoid pressure release
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Kong Eric You-Ten, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Endotracheal Intubation and General Anesthesia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 4 inclusion and 5 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 18 Jun 2019. 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 Canada. 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?
Contact Kong Eric You-Ten, MD (416-586-4800 ext. 5270, eric.you-ten@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cricoid pressure effectiveness (time frame: 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 18 Jun 2019.