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The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.
The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.
The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.
Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fastrach | Experimental | 50 persons beeing intubated using the Fastrach. |
|
| GlideScope | Experimental | 50 persons beeing intubated using the GlideScope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlideScope | Device | The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Intubated in the First Attempt | The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation). | please see description |
| Time to Intubate | From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph. |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest Saturation During Intubation. | measured on the monitor | |
| Mucosal Lesion | inspection during intubation and one hour postop. | |
| Subjectively Intubation Difficulty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mogens VY Nielsen, MD | Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Copenhagen University Hospital | Glostrup | Region Sjælland | 2600 | Denmark | ||
Exclusion: severe mental disorder, greater alcohol consumption than recommended by the Danish Health Authority, drug abuse, previously impossible mask ventilation or intubation with the GS and/or FT, the need for RSI and if the anaesthetist responsible determined that the patient should be treated differently than described in the protocol.
The study was conducted from September 2010 to January 2011. Patients were recuted from two hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fastrach | 50 persons beeing intubated using the Fastrach. |
| FG001 | GlideScope | 50 persons beeing intubated using the GlideScope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fastrach | 50 persons beeing intubated using the Fastrach. |
| BG001 | GlideScope | 50 persons beeing intubated using the GlideScope. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Intubated in the First Attempt | The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation). | Posted | Number | participants | please see description |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fastrach | 50 persons beeing intubated using the Fastrach. |
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Acta Anaesthesiol Scand 2012; 56: 755-761
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mogens Ydemann | Department of Anaesthesiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark | +4531155995 | clinicaltrials@ydemann.dk |
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| Fastrach | Device | The Fastrach is an intubation laryngeal mask. |
|
| measured immediately on a visual analogue scale. |
| Intubation of the Esophagus. | detected immediately |
| Postoperative Hoarseness. | one hour postoperative. |
| Postoperative Throat Pain. | one hour postoperative |
| Privathospitalet Hamlet |
| Soeborg |
| Region Sjælland |
| 2860 |
| Denmark |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Lowest Saturation During Intubation. | Not Posted | measured on the monitor |
| Secondary | Mucosal Lesion | Not Posted | inspection during intubation and one hour postop. |
| Secondary | Subjectively Intubation Difficulty | Not Posted | measured immediately on a visual analogue scale. |
| Secondary | Intubation of the Esophagus. | Not Posted | detected immediately |
| Secondary | Postoperative Hoarseness. | Not Posted | one hour postoperative. |
| Secondary | Postoperative Throat Pain. | Not Posted | one hour postoperative |
| Primary | Time to Intubate | The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used. | Posted | Mean | 95% Confidence Interval | sec | From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph. |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | GlideScope | 50 persons beeing intubated using the GlideScope. | 0 | 50 | 0 | 50 |
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