Intubation IntraesophagealNCT01357824
Fibreoptic Intubation With and Without Sellick´s Maneuver
An observational study of Intubation Intraesophageal and Respiratory Aspiration of Gastric Contents, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation Intraesophageal, Respiratory Aspiration of Gastric Contents
- What is being tested?
- Application of Sellick´s maneuver.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- 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
Study population: Patients admitted for elective surgery at Glostrup University Hospital
Who may be able to join
- ASA I-II
- Informed consent to participate in the study
- Age 18 or older
- Predicted difficult airways
Who cannot join
- Body mass index more then 35
- Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Operations- og Anæstesilogisk afd Y, Glostrup Hospital
Glostrup Municipality, 2600
About this study
Official title: View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.
The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.
Read the detailed description
The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction.
The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied.
The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.
- Being tested
- Application of Sellick´s maneuver.
- Keywords
- Intubation, Sellick´s maneuver, aspiration, [E05.497.578]
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Sellick´s maneuver.Procedure or surgery
The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted for elective surgery | The patient admitted for elective surgery can be included, and will both the case and control, as we intubate the same patient twice, with and without Sellick´s maneuver. Receives: Procedure: Application of Sellick´s maneuver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of intubation
The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver
Measured: 180 seconds
Secondary outcomes (3)
Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver
Patients that is not intubated after 120 seconds in each trial, will count as "not intubated after 120 seconds".
Measured: 180 seconds
Fall of oxygen saturation after intubation with and without Sellick´s maneuver.
The investigators measure the oxygen saturation on a finger device at the beginning and the and of the intubations.
Measured: 180 seconds
Visualization of the vocal cords
The investigators will observe the visualization of the vocal cords, and provide the result on the Cormack Score.
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation IntraesophagealStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
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, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357824
- Sponsor's protocol ID
- Glostrup Crich Study
- Status last verified
- Jan 2012
- First submitted
- 19 May 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith CE, Boyer D. Cricoid pressure decreases ease of tracheal intubation using fibreoptic laryngoscopy (WuScope System. Can J Anaesth. 2002 Jun-Jul;49(6):614-9. doi: 10.1007/BF03017391.
PubMed 12067876Asai T, Goy RW, Liu EH. Cricoid pressure prevents placement of the laryngeal tube and laryngeal tube-suction II. Br J Anaesth. 2007 Aug;99(2):282-5. doi: 10.1093/bja/aem159. Epub 2007 Jun 15.
PubMed 17573388Haslam N, Parker L, Duggan JE. Effect of cricoid pressure on the view at laryngoscopy. Anaesthesia. 2005 Jan;60(1):41-7. doi: 10.1111/j.1365-2044.2004.04010.x.
PubMed 15601271Brisson P, Brisson M. Variable application and misapplication of cricoid pressure. J Trauma. 2010 Nov;69(5):1182-4. doi: 10.1097/TA.0b013e3181d2793e.
PubMed 21068621Ellis DY, Harris T, Zideman D. Cricoid pressure in emergency department rapid sequence tracheal intubations: a risk-benefit analysis. Ann Emerg Med. 2007 Dec;50(6):653-65. doi: 10.1016/j.annemergmed.2007.05.006. Epub 2007 Aug 3.
PubMed 17681642Priebe HJ. Cricoid pressure: an expert's opinion. Minerva Anestesiol. 2009 Dec;75(12):710-4.
PubMed 19940824
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.
- ClinicalTrials.gov ID
- NCT01357824
- Acronym / sponsor ID
- Glostrup Crich Study
- Keywords
- Intubation, Sellick´s maneuver, aspiration, [E05.497.578]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 May 2011 (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.
The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.
Detailed description
The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction.
The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied.
The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted for elective surgery | – | Procedure: Application of Sellick´s maneuver.The patient admitted for elective surgery can be included, and will both the case and control, as we intubate the same patient twice, with and without Sellick´s maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for elective surgery at Glostrup University Hospital
Key inclusion criteria (4 listed)
- ASA I-II
- Informed consent to participate in the study
- Age 18 or older
- Predicted difficult airways
Key exclusion criteria (2 listed)
- Body mass index more then 35
- Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)
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 |
|---|---|---|
| Application of Sellick´s maneuver.The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat. | Procedure or surgery | Patients admitted for elective surgery |
Primary outcome
Time of intubation
Time frame: 180 seconds
The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver
3 secondary outcomes
Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver
Time frame: 180 seconds
Fall of oxygen saturation after intubation with and without Sellick´s maneuver.
Time frame: 180 seconds
Visualization of the vocal cords
Time frame: 180 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 31 Jan 2012.
- Background: PubMed 12067876Smith CE, Boyer D. Cricoid pressure decreases ease of tracheal intubation using fibreoptic laryngoscopy (WuScope System. Can J Anaesth. 2002 Jun-Jul;49(6):614-9. doi: 10.1007/BF03017391.
- Background: PubMed 17573388Asai T, Goy RW, Liu EH. Cricoid pressure prevents placement of the laryngeal tube and laryngeal tube-suction II. Br J Anaesth. 2007 Aug;99(2):282-5. doi: 10.1093/bja/aem159. Epub 2007 Jun 15.
- Background: PubMed 15601271Haslam N, Parker L, Duggan JE. Effect of cricoid pressure on the view at laryngoscopy. Anaesthesia. 2005 Jan;60(1):41-7. doi: 10.1111/j.1365-2044.2004.04010.x.
- Background: PubMed 21068621Brisson P, Brisson M. Variable application and misapplication of cricoid pressure. J Trauma. 2010 Nov;69(5):1182-4. doi: 10.1097/TA.0b013e3181d2793e.
- Background: PubMed 17681642Ellis DY, Harris T, Zideman D. Cricoid pressure in emergency department rapid sequence tracheal intubations: a risk-benefit analysis. Ann Emerg Med. 2007 Dec;50(6):653-65. doi: 10.1016/j.annemergmed.2007.05.006. Epub 2007 Aug 3.
- Background: PubMed 19940824Priebe HJ. Cricoid pressure: an expert's opinion. Minerva Anestesiol. 2009 Dec;75(12):710-4.
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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.
Bjørn Arenkiel, MD principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Intraesophageal and Respiratory Aspiration of Gastric Contents, 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 2 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 31 Jan 2012. 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?
Time of intubation (time frame: 180 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357824, which also lists 6 linked publications.
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 31 Jan 2012.