Airway ManagementNCT01679626
Airway Manoeuvers - Implications for Airway Management?
An observational study of Airway Management, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2011to Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation.
Who may be able to join
- 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation
Who cannot join
- BMI > 35 kg.m-2);
- chronic obstructive pulmonary disease;
- history of difficult intubation;
- mouth opening < 3 cm;
- inadequate neck mobility;
- history of oropharyngeal pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cricoid Pressure and Backward Upward Rightward Pressure on Airway Dimensions - Implications for Airway Management?
In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation.
The investigators hypothesize that by giving this pressure the effective work area is likely to be smaller. The investigators would like to quantify this effect by measuring the effective work area, using a specially designed computer program.
Read the detailed description
Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are extralaryngeal manoeuvers which are widely applied during endotracheal intubation, respectively offering potential protection against passive gastric regurgitation and improved laryngeal view in emergency airway management.
Their validity in achieving an improvement of the laryngeal view has been questioned.
The objective of this study is to measure the change in mean anterior-posterior rima glottidis (APRIMA) distance and mean area under the vocal cords after backward upward rightward pressure (BURP) and cricoid pressure (CP).
The investigators will measure the APRIMA distances and areas under the vocal cords, using a specially created module in the program DeVIDE. The measurements assessed during BURP and CP will be expressed relative to the measurements when no external pressure is applied.
- Conditions
- Airway Management
- Keywords
- cricoid pressure (CP), backward upward rightward pressure (BURP), AP-rima distances, Glottic area, Extralaryngeal manoeuvres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Maassen, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679626
- Sponsor's protocol ID
- 2011-06
- Status last verified
- Sep 2012
- First submitted
- 3 Sep 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cricoid Pressure and Backward Upward Rightward Pressure on Airway Dimensions - Implications for Airway Management?
- ClinicalTrials.gov ID
- NCT01679626
- Acronym / sponsor ID
- 2011-06
- Conditions
- Airway Management
- Keywords
- cricoid pressure (CP), backward upward rightward pressure (BURP), AP-rima distances, Glottic area, Extralaryngeal manoeuvres
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Sep 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.
In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation.
The investigators hypothesize that by giving this pressure the effective work area is likely to be smaller. The investigators would like to quantify this effect by measuring the effective work area, using a specially designed computer program.
Detailed description
Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are extralaryngeal manoeuvers which are widely applied during endotracheal intubation, respectively offering potential protection against passive gastric regurgitation and improved laryngeal view in emergency airway management.
Their validity in achieving an improvement of the laryngeal view has been questioned.
The objective of this study is to measure the change in mean anterior-posterior rima glottidis (APRIMA) distance and mean area under the vocal cords after backward upward rightward pressure (BURP) and cricoid pressure (CP).
The investigators will measure the APRIMA distances and areas under the vocal cords, using a specially created module in the program DeVIDE. The measurements assessed during BURP and CP will be expressed relative to the measurements when no external pressure is applied.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation.
Key inclusion criteria (1 listed)
- 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation
Key exclusion criteria (6 listed)
- BMI > 35 kg.m-2);
- chronic obstructive pulmonary disease;
- history of difficult intubation;
- mouth opening < 3 cm;
- inadequate neck mobility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Sep 2012.
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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?
An observational study of Airway Management, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 1 inclusion and 6 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 7 Sep 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 Netherlands. 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.
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 7 Sep 2012.