Esophagogastroduodensocopy (EGD) Procedure
Conditions
Brief summary
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.
Interventions
DEVICECuffed ETT
Cuffed endotracheal tube.
DEVICECuffed LMA
Cuffed laryngeal mask airway.
Sponsors
Mineto Kamata
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.
Exclusion criteria
* Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracuff Pressures During Probe Insertion | At time of EGD probe insertion | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion. |
| Intracuff Pressure With Probe in Place | At time of EGD while probe is in place | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place. |
| Intracuff Pressure After Probe Removal | Immediately after probe removal | Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LMA 2 Airway secured using a size 2 laryngeal mask airway. | 15 |
| LMA 2.5 Airway secured using a size 2.5 laryngeal mask airway. | 15 |
| LMA 3 Airway secured using a size 3 laryngeal mask airway. | 33 |
| LMA 4 Airway secured using a size 4 laryngeal mask airway. | 24 |
| Cuffed ETT Airway secured using a cuffed endotracheal tube. | 13 |
| Total | 100 |
Baseline characteristics
| Characteristic | LMA 2 | LMA 2.5 | LMA 3 | LMA 4 | Cuffed ETT | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 33 Participants | 24 Participants | 13 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Intracuff pressure immediately following intubation | 15 cmH2O STANDARD_DEVIATION 13 | 25 cmH2O STANDARD_DEVIATION 10 | 34 cmH2O STANDARD_DEVIATION 10 | 32 cmH2O STANDARD_DEVIATION 10 | 19 cmH2O STANDARD_DEVIATION 26 | 27 cmH2O STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 19 Participants | 10 Participants | 7 Participants | 52 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants | 14 Participants | 6 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 33 | 0 / 24 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 33 | 0 / 24 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 33 | 0 / 24 | 0 / 13 |
Outcome results
Primary
Intracuff Pressure After Probe Removal
Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.
Time frame: Immediately after probe removal
Population: Number of participants analyzed in each row is number that received each type of airway.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMA 2 | Intracuff Pressure After Probe Removal | 15 cmH2O | Standard Deviation 11 |
| LMA 2.5 | Intracuff Pressure After Probe Removal | 26 cmH2O | Standard Deviation 10 |
| LMA 3 | Intracuff Pressure After Probe Removal | 31 cmH2O | Standard Deviation 11 |
| LMA 4 | Intracuff Pressure After Probe Removal | 29 cmH2O | Standard Deviation 10 |
| Cuffed ETT | Intracuff Pressure After Probe Removal | 21 cmH2O | Standard Deviation 25 |
Primary
Intracuff Pressures During Probe Insertion
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
Time frame: At time of EGD probe insertion
Population: Number of participants that received each type of airway.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMA 2 | Intracuff Pressures During Probe Insertion | 22 cmH2O | Standard Deviation 14 |
| LMA 2.5 | Intracuff Pressures During Probe Insertion | 34 cmH2O | Standard Deviation 9 |
| LMA 3 | Intracuff Pressures During Probe Insertion | 41 cmH2O | Standard Deviation 15 |
| LMA 4 | Intracuff Pressures During Probe Insertion | 37 cmH2O | Standard Deviation 12 |
| Cuffed ETT | Intracuff Pressures During Probe Insertion | 24 cmH2O | Standard Deviation 25 |
Primary
Intracuff Pressure With Probe in Place
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.
Time frame: At time of EGD while probe is in place
Population: Number of participants analyzed in each row is number that received each type of airway.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMA 2 | Intracuff Pressure With Probe in Place | 22 cmH2O | Standard Deviation 14 |
| LMA 2.5 | Intracuff Pressure With Probe in Place | 35 cmH2O | Standard Deviation 9 |
| LMA 3 | Intracuff Pressure With Probe in Place | 39 cmH2O | Standard Deviation 13 |
| LMA 4 | Intracuff Pressure With Probe in Place | 36 cmH2O | Standard Deviation 11 |
| Cuffed ETT | Intracuff Pressure With Probe in Place | 24 cmH2O | Standard Deviation 25 |