AspirationCPNCT01415661
Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
A study testing cricoid pressure in people with Aspiration, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
Trial summary
This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Aspiration
- What is being tested?
- cricoid pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2011to Sep 2011
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese patients ( BMI 40-70 kg/m2)
- No Contre indication to cricoid pressure
- No-obese patients (BMI < 40)
Who cannot join
- ASA 3 and 4
- Contre indication to cricoid pressure
Trial locations and contacts
1 site in 1 country.
About this study
This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).
Read the detailed description
Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.
- Conditions
- Aspiration
- Being tested
- cricoid pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cricoid pressureOther
Also called Glidescope
The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP.
| Study group | Role | What they receive |
|---|---|---|
| obese patient | Experimental | Not described Receives: Other: cricoid pressure |
| non obese patient | Experimental | Not described Receives: Other: cricoid pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Cricoid Pressure for Prevention of Aspiration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Riaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahed ZEIDAN, Procare Riaya Hospital
- Investigators
- AHED ZEIDAN, MD, Study chair, Procare Riaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415661
- Sponsor's protocol ID
- PRH 01
- Acronym
- CP
- Status last verified
- Apr 2012
- First submitted
- 4 Aug 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
- ClinicalTrials.gov ID
- NCT01415661
- Acronym / sponsor ID
- CP / PRH 01
- Conditions
- Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Procare Riaya HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Aug 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.
This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).
Detailed description
Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese patient | Experimental | Other: cricoid pressure |
| non obese patient | Experimental | Other: cricoid pressure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese patients ( BMI 40-70 kg/m2)
- No Contre indication to cricoid pressure
- No-obese patients (BMI < 40)
Key exclusion criteria (2 listed)
- ASA 3 and 4
- Contre indication to cricoid pressure
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: GlidescopeThe current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP. | Other | non obese patient, obese patient |
Primary outcome
Efficacy of Cricoid Pressure for Prevention of Aspiration
Time frame: 24 hours
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 10 Apr 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.
AHED ZEIDAN, MD study chair
Procare Riaya 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 cricoid pressure in people with Aspiration, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
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 3 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 10 Apr 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 Saudi Arabia. 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?
Efficacy of Cricoid Pressure for Prevention of Aspiration (time frame: 24 hours). 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 10 Apr 2012.