Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glidescope | Active Comparator | A device for endotracheal intubation. |
|
| Storz | Active Comparator | A device for endotracheal intubation. |
|
| Standard Laryngoscope | Active Comparator | A device for endotracheal intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal intubation | Device | Endotracheal intubation |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ghazal, MD | Loma Linda University Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Department of Anesthesiology | Loma Linda | California | 92354 | United States | ||
| Loma Linda University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Glidescope | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation |
| FG001 | Storz | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation |
| FG002 | Standard Laryngoscope | A device for endotracheal intubation Endotracheal intubation: Endotracheal intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glidescope | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation |
| BG001 | Storz | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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 to successful tracheal intubation | Posted | Mean | 95% Confidence Interval | Seconds | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glidescope | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation |
Not provided
Not provided
Trainees reported more prior intubation experience using DL than the other laryngoscopes, so we were unable to equalize prior clinical experience between DL & other laryngoscopes. Assessment of learning effect limited by intubation types within study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Ghazal, MD | Loma Linda University Department of Anesthesiology | 909-558-4475 | EGhazal@llu.edu |
Not provided
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Loma Linda |
| California |
| 92354 |
| United States |
| BG002 | Standard Laryngoscope | A device for endotracheal intubation Endotracheal intubation: Endotracheal intubation |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA Status I | ASA status was assigned based on standard American Society for Anesthesiologists guidelines, ASA I = healthy. All patients undergoing an anesthetic are assigned and ASA status. | Count of Participants | Participants |
|
| ASA Status II | ASA status was assigned based on standard American Society for Anesthesiologists guidelines. ASA II = mild systemic disease. All patients undergoing an anesthetic are assigned and ASA status. | Count of Participants | Participants |
|
| ASA Status III | ASA status was assigned based on standard American Society for Anesthesiologists guidelines. ASA III = moderate to severe systemic disease. All patients undergoing an anesthetic are assigned and ASA status. | Count of Participants | Participants |
|
| ASA Status IV | ASA status was assigned based on standard American Society for Anesthesiologists guidelines. ASA IV = severe systemic disease that is a constant threat to life. All patients undergoing an anesthetic are assigned and ASA status. | Count of Participants | Participants |
|
| Weight | Mean | Full Range | Kg |
|
| Percentile Weight for Length | Median | Full Range | Percentile |
|
| OG002 | Standard Laryngoscope | A device for endotracheal intubation Endotracheal intubation: Endotracheal intubation |
|
|
| 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. | Posted | Count of Participants | Participants | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. |
|
|
|
| Secondary | Successful Intubation After Two Laryngoscopy Attempts | Posted | Count of Participants | Participants | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. |
|
|
|
| Secondary | Successful Intubation After Three Laryngoscopy Attempts | Posted | Count of Participants | Participants | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. |
|
|
|
| Secondary | Successful Intubation After Four Laryngoscopy Attempts | Posted | Count of Participants | Participants | Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Storz | A device for endotracheal intubation. Endotracheal intubation: Endotracheal intubation | 0 | 22 | 0 | 22 |
| EG002 | Standard Laryngoscope | A device for endotracheal intubation Endotracheal intubation: Endotracheal intubation | 0 | 19 | 0 | 19 |
Not provided
Not provided
Not provided