Endotracheal Intubation
Conditions
Keywords
breathing tube placement
Brief summary
This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.
Interventions
DEVICEEndotracheal intubation
Endotracheal intubation
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 23 Months
Healthy volunteers
No
Inclusion criteria
* Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study
Exclusion criteria
* Children with increased pulmonary aspiration risk; * Prior documentation of difficult endotracheal intubation; * Those that lack legal representative consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Intubation After One Laryngoscopy Attempt | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. | Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful. |
| Successful Intubation After Two Laryngoscopy Attempts | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. | — |
| Successful Intubation After Three Laryngoscopy Attempts | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. | — |
| Successful Intubation After Four Laryngoscopy Attempts | Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glidescope A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation | 22 |
| Storz A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation | 22 |
| Standard Laryngoscope A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation | 19 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Glidescope | Storz | Standard Laryngoscope | Total |
|---|---|---|---|---|
| Age, Continuous | 7.6 Months | 8.5 Months | 8.1 Months | 8.1 Months |
| ASA Status I | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| ASA Status II | 13 Participants | 12 Participants | 9 Participants | 34 Participants |
| ASA Status III | 3 Participants | 5 Participants | 6 Participants | 14 Participants |
| ASA Status IV | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Percentile Weight for Length | 71.9 Percentile | 58.5 Percentile | 72.1 Percentile | 71.9 Percentile |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 6 Participants | 26 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 13 Participants | 37 Participants |
| Weight | 8.2 Kg | 8.0 Kg | 8.0 Kg | 8.0 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 19 |
Outcome results
Primary
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
Population: Time to successful tracheal intubation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glidescope | Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. | 30.8 Seconds |
| Storz | Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. | 42.1 Seconds |
| Standard Laryngoscope | Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. | 21.5 Seconds |
Secondary
Successful Intubation After Four Laryngoscopy Attempts
Time frame: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope | Successful Intubation After Four Laryngoscopy Attempts | 1 Participants |
| Storz | Successful Intubation After Four Laryngoscopy Attempts | 0 Participants |
| Standard Laryngoscope | Successful Intubation After Four Laryngoscopy Attempts | 0 Participants |
Secondary
Successful Intubation After One Laryngoscopy Attempt
Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope | Successful Intubation After One Laryngoscopy Attempt | 17 Participants |
| Storz | Successful Intubation After One Laryngoscopy Attempt | 16 Participants |
| Standard Laryngoscope | Successful Intubation After One Laryngoscopy Attempt | 16 Participants |
Secondary
Successful Intubation After Three Laryngoscopy Attempts
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope | Successful Intubation After Three Laryngoscopy Attempts | 1 Participants |
| Storz | Successful Intubation After Three Laryngoscopy Attempts | 1 Participants |
| Standard Laryngoscope | Successful Intubation After Three Laryngoscopy Attempts | 1 Participants |
Secondary
Successful Intubation After Two Laryngoscopy Attempts
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glidescope | Successful Intubation After Two Laryngoscopy Attempts | 3 Participants |
| Storz | Successful Intubation After Two Laryngoscopy Attempts | 5 Participants |
| Standard Laryngoscope | Successful Intubation After Two Laryngoscopy Attempts | 2 Participants |