Cricoid Pressure During Tracheal IntubationNCT04481854
Cricoid Pressure Versus Paratracheal Pressure
A study testing cricoid pressure and left paratracheal pressure in people with Cricoid Pressure During Tracheal Intubation, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cricoid Pressure During Tracheal Intubation
- What is being tested?
- cricoid pressure and left paratracheal pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Jan 2020to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with no criteria of difficult intubation or mask ventilation
- no criteria of full stomach requiring crush induction
Who cannot join
- Unexpected difficult laryngoscopy or mask ventilation
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi Slim Hospital
Tunis, 2046
Mhamed Sami Mebazaa, professor, 0021622252589, msmebazaa@gmail.com
Asma Ben Souissi, Ass Prof, 0021698336883, bsouissiasma@gmail.com
About this study
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.
Read the detailed description
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.
During the laryngoscopy, the modification of the Cormack and Lehane grade before and after the application of the cricoid or paratracheal pressure will be noticed.
concerning the effectiveness of the procedure, a gastric tube will be introduced through the oesophagus during the procedure, under direct vision.
- Being tested
- cricoid pressure, left paratracheal pressure
- Keywords
- cricoid pressure, paratracheal pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cricoid pressureProcedure or surgery
cricoid pressure during laryngoscopy
left paratracheal pressureProcedure or surgery
left paratracheal pressure during laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Cricoid pressure group | Experimental | Patients of this group will recieve cricoid pressure during direct laryngoscopy. Receives: Procedure: cricoid pressure |
| left paratracheal pressure group | Experimental | Patients of this group will recieve left paratracheal pressure during direct laryngoscopy. Receives: Procedure: left paratracheal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of Cormack and Lehane grade
Cormack and Lehane grade before and after the procedure
Measured: 3 minutes after induction of general anesthesia
Secondary outcomes (1)
Effectiveness of the pressure
Possibility to introduce a gastric tube through the oesophagus
Measured: 5 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start30 Jan 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cricoid Pressure During Tracheal 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized to recieve cricoid pressure or left paratracheal pressure
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481854
- Sponsor's protocol ID
- Sellick vs paratracheal
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cricoid Pressure Versus Paratracheal Pressure
- ClinicalTrials.gov ID
- NCT04481854
- Acronym / sponsor ID
- Sellick vs paratracheal
- Keywords
- cricoid pressure, paratracheal pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 22 Jul 2020 (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.
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.
Detailed description
Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.
During the laryngoscopy, the modification of the Cormack and Lehane grade before and after the application of the cricoid or paratracheal pressure will be noticed.
concerning the effectiveness of the procedure, a gastric tube will be introduced through the oesophagus during the procedure, under direct vision.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- patients will be randomized to recieve cricoid pressure or left paratracheal pressure
| Arm | Type | Receives |
|---|---|---|
| Cricoid pressure group | Experimental | Procedure: cricoid pressurePatients of this group will recieve cricoid pressure during direct laryngoscopy. |
| left paratracheal pressure group | Experimental | Procedure: left paratracheal pressurePatients of this group will recieve left paratracheal pressure during direct laryngoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients with no criteria of difficult intubation or mask ventilation
- no criteria of full stomach requiring crush induction
Key exclusion criteria (1 listed)
- Unexpected difficult laryngoscopy or 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 |
|---|---|---|
| cricoid pressurecricoid pressure during laryngoscopy | Procedure or surgery | Cricoid pressure group |
| left paratracheal pressureleft paratracheal pressure during laryngoscopy | Procedure or surgery | left paratracheal pressure group |
Primary outcome
Modification of Cormack and Lehane grade
Time frame: 3 minutes after induction of general anesthesia
Cormack and Lehane grade before and after the procedure
1 secondary outcome
Effectiveness of the pressure
Time frame: 5 minutes after induction of general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cricoid pressure and left paratracheal pressure in people with Cricoid Pressure During Tracheal Intubation, run by Mongi Slim Hospital at 1 site in Tunisia.
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 1 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 29 Jul 2020. 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 Tunisia. 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 Mhamed Sami Mebazaa, professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of Cormack and Lehane grade (time frame: 3 minutes after induction of general anesthesia). 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 29 Jul 2020.