Intubationattempts, Intubationtime, Morbidly Obese
Conditions
Brief summary
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®.
Detailed description
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.
Interventions
DEVICEGlideScope
The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.
DEVICEFastrach
The Fastrach is an intubation laryngeal mask.
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* BMI \>/= 35
Exclusion criteria
* need for crash induction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Intubated in the First Attempt | please see description | 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). |
| Time to Intubate | From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjectively Intubation Difficulty | measured immediately on a visual analogue scale. |
| Intubation of the Esophagus. | detected immediately |
| Lowest Saturation During Intubation. | measured on the monitor |
| Postoperative Throat Pain. | one hour postoperative |
| Postoperative Hoarseness. | one hour postoperative. |
| Mucosal Lesion | inspection during intubation and one hour postop. |
Countries
Denmark
Participant flow
Recruitment details
The study was conducted from September 2010 to January 2011. Patients were recuted from two hospitals.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fastrach 50 persons beeing intubated using the Fastrach. | 50 |
| GlideScope 50 persons beeing intubated using the GlideScope. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | GlideScope | Fastrach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 43 years | 42 years | 42 years FULL_RANGE 999999 |
| Region of Enrollment Denmark | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 43 Participants | 33 Participants | 76 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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).
Time frame: please see description
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fastrach | Number of Patients Intubated in the First Attempt | 42 participants |
| GlideScope | Number of Patients Intubated in the First Attempt | 46 participants |
Primary
Time to Intubate
Time frame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fastrach | Time to Intubate | 61 sec |
| GlideScope | Time to Intubate | 49 sec |
Secondary
Intubation of the Esophagus.
Time frame: detected immediately
Secondary
Lowest Saturation During Intubation.
Time frame: measured on the monitor
Secondary
Mucosal Lesion
Time frame: inspection during intubation and one hour postop.
Secondary
Postoperative Hoarseness.
Time frame: one hour postoperative.
Secondary
Postoperative Throat Pain.
Time frame: one hour postoperative
Secondary
Subjectively Intubation Difficulty
Time frame: measured immediately on a visual analogue scale.