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
Not provided
A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cuffed ETT | Airway secured using a cuffed endotracheal tube. |
| |
| LMA 2 | Airway secured using a size 2 laryngeal mask airway. |
| |
| LMA 2.5 | Airway secured using a size 2.5 laryngeal mask airway. |
| |
| LMA 3 | Airway secured using a size 3 laryngeal mask airway. |
| |
| LMA 4 | Airway secured using a size 4 laryngeal mask airway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cuffed ETT | Device | Cuffed endotracheal tube. |
| |
| Cuffed LMA |
| Measure | Description | Time Frame |
|---|---|---|
| Intracuff Pressures During Probe Insertion | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion. | At time of EGD probe insertion |
| Intracuff Pressure With Probe in Place | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place. | At time of EGD while probe is in place |
| Intracuff Pressure After Probe Removal | Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed. | Immediately after probe removal |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cuffed ETT | Airway secured using a cuffed endotracheal tube. |
| FG001 | LMA 2 | Airway secured using a size 2 laryngeal mask airway. |
| FG002 | LMA 2.5 | Airway secured using a size 2.5 laryngeal mask airway. |
| FG003 | LMA 3 | Airway secured using a size 3 laryngeal mask airway. |
| FG004 | LMA 4 | Airway secured using a size 4 laryngeal mask airway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LMA 2 | Airway secured using a size 2 laryngeal mask airway. |
| BG001 | LMA 2.5 | Airway secured using a size 2.5 laryngeal mask airway. |
| 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 | Intracuff Pressures During Probe Insertion | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion. | Number of participants that received each type of airway. | Posted | Mean | Standard Deviation | cmH2O | At time of EGD probe insertion |
|
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 | LMA 2 | Airway secured using a size 2 laryngeal mask airway. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mineto Kamada | Nationwide Children's Hospital | 6147224200 | mineto.kamata@gmail.com |
Not provided
Not provided
Not provided
Not provided
| Device |
Cuffed laryngeal mask airway. |
|
| BG002 | LMA 3 | Airway secured using a size 3 laryngeal mask airway. |
| BG003 | LMA 4 | Airway secured using a size 4 laryngeal mask airway. |
| BG004 | Cuffed ETT | Airway secured using a cuffed endotracheal tube. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Intracuff pressure immediately following intubation | Number of participants analyzed in each row is number that received each type of airway. | Mean | Standard Deviation | cmH2O |
|
Airway secured using a size 3 laryngeal mask airway.
| OG003 | LMA 4 | Airway secured using a size 4 laryngeal mask airway. |
| OG004 | Cuffed ETT | Airway secured using a cuffed endotracheal tube. |
|
|
| Primary | Intracuff Pressure With Probe in Place | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place. | Number of participants analyzed in each row is number that received each type of airway. | Posted | Mean | Standard Deviation | cmH2O | At time of EGD while probe is in place |
|
|
|
| Primary | Intracuff Pressure After Probe Removal | Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed. | Number of participants analyzed in each row is number that received each type of airway. | Posted | Mean | Standard Deviation | cmH2O | Immediately after probe removal |
|
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | LMA 2.5 | Airway secured using a size 2.5 laryngeal mask airway. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | LMA 3 | Airway secured using a size 3 laryngeal mask airway. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | LMA 4 | Airway secured using a size 4 laryngeal mask airway. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG004 | Cuffed ETT | Airway secured using a cuffed endotracheal tube. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided