Respiratory AspirationNCT01635179
Laryngeal View With Videolaryngoscopy
A study testing Cricoid pressure in people with Respiratory Aspiration and Hypoxemia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Aspiration, Hypoxemia
- What is being tested?
- Cricoid pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Sep 2012
- 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
- ASA 1-2, BMI < 35,
- no indication for rapid sequence induction,
- age > 18,
- able to give consent.
Who cannot join
- ASA > 2,
- BMI > 35,
- RSI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.
To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration.
The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy.
The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.
- Conditions
- Respiratory Aspiration, Hypoxemia
- Being tested
- Cricoid pressure
- Keywords
- Videolaryngoscopy, Bronchial Aspiration, Hypoxia
- Medical subject headings
- Respiratory Aspiration, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid pressureProcedure or surgery
Also called Sellicks maneuver., Profylaxis of bronchial aspiration
The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Cricoid pressure | Experimental | A cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction. Receives: Procedure: Cricoid pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed intubation within 120 seconds
The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.
Measured: 120 seconds
Secondary outcomes (1)
A description of the laryngeal inlet
The secondary outcome measure is a description of the laryngeal inlet according the the Cormack-Lehan system, and how Sellicks Maneuver alters that view.
Measured: 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory AspirationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Arenkiel, Glostrup University Hospital, Copenhagen
- Investigators
- Bjørn Arenkiel, MD, Principal investigator, GlustrupUH dept of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635179
- Sponsor's protocol ID
- Glo-anaest-2012
- Status last verified
- Apr 2013
- First submitted
- 19 Jun 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.
- ClinicalTrials.gov ID
- NCT01635179
- Acronym / sponsor ID
- Glo-anaest-2012
- Conditions
- Respiratory Aspiration, Hypoxemia
- Keywords
- Videolaryngoscopy, Bronchial Aspiration, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Jul 2012 (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.
To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration.
The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy.
The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cricoid pressure | Experimental | Procedure: Cricoid pressureA cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1-2, BMI < 35,
- no indication for rapid sequence induction,
- age > 18,
- able to give consent.
Key exclusion criteria (3 listed)
- ASA > 2,
- BMI > 35,
- RSI
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 pressureAlso: Sellicks maneuver., Profylaxis of bronchial aspirationThe patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy. | Procedure or surgery | Cricoid pressure |
Primary outcome
Completed intubation within 120 seconds
Time frame: 120 seconds
The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.
1 secondary outcome
A description of the laryngeal inlet
Time frame: 120 seconds
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 25 Apr 2013.
Related trials for Respiratory Aspiration
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults
Spontaneous Breathing Trial in ICU
RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
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.
Bjørn Arenkiel, MD principal investigator
GlustrupUH dept of Anaesthesia
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 in people with Respiratory Aspiration and Hypoxemia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 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 25 Apr 2013. 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 Denmark. 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?
Completed intubation within 120 seconds (time frame: 120 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 25 Apr 2013.