Tracheal Intubation
Conditions
Keywords
Tracheal intubation, Laryngoscopy, videolaryngoscope, McGrath, success, time
Brief summary
The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties. The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.
Interventions
DEVICEMcGrath
Tracheal intubation, using Mcgrath video-laryngoscope
DEVICETracheal intubation using Macintosh Laryngoscope
Tracheal intubation using Macintosh Laryngoscope
Sponsors
NHS Grampian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18 years and over) scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade after induction of general anaesthesia and who have given valid informed consent.
Exclusion criteria
* Patients requiring special techniques for intubation such as rapid sequence induction * Adults who have learning difficulties * Are unconscious or very severely ill * Have a terminal illness; are in an emergency situation * Have a mental illness * Have dementia * Prisoners * Those who could be considered to have a particularly dependent relationship with the investigator and other vulnerable groups.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | At intubation | Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of View of the Vocal Cords | At analysis | — |
| Number of Attempts to Secure Successful Intubation | At analysis | Is there a difference in the number of attempts required to secure successful intubation ? |
| Incidence of Initial Oesophageal Intubation | At analysis | — |
| Difference in Learning to Use the Scopes | At analysis | Is there a difference between trainee anaesthetists in learning to use the scopes |
| Incidence of Low Arterial Saturation During Intubation | At analysis | — |
| Incidence of Visible Trauma to the Airway | At analysis | — |
| Number of Intubations Taking More Than 70 Seconds | At Analysis | — |
Countries
United Kingdom
Participant flow
Recruitment details
adult patients undergoing elective tracheal intubation at induction of anaesthesia Between February and August 2008
Pre-assignment details
139 patients consented for study. 120 assigned to groups. 19 not studied: no McGrath® scope available (n=10). No direct supervision of intubator (n=6). Case cancellation or changes (n=3).
Participants by arm
| Arm | Count |
|---|---|
| McGrath Tracheal Intubation using McGrath video-laryngoscope | 60 |
| Macintosh Tracheal intubation using Macintosh Laryngoscope | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | McGrath | Macintosh | Total |
|---|---|---|---|
| Age, Customized | 48 Years | 60.5 Years | 54 Years |
| Region of Enrollment United Kingdom | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 43 Participants | 41 Participants | 84 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Intubation Time
Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation
Time frame: At intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| McGrath | Intubation Time | 47.0 seconds |
| Macintosh | Intubation Time | 29.5 seconds |
p-value: <0.01Log Rank
Secondary
Difference in Learning to Use the Scopes
Is there a difference between trainee anaesthetists in learning to use the scopes
Time frame: At analysis
Secondary
Incidence of Initial Oesophageal Intubation
Time frame: At analysis
Secondary
Incidence of Low Arterial Saturation During Intubation
Time frame: At analysis
Secondary
Incidence of Visible Trauma to the Airway
Time frame: At analysis
Secondary
Number of Attempts to Secure Successful Intubation
Is there a difference in the number of attempts required to secure successful intubation ?
Time frame: At analysis
Secondary
Number of Intubations Taking More Than 70 Seconds
Time frame: At Analysis
Secondary
Quality of View of the Vocal Cords
Time frame: At analysis