Pyloric Stenosis, Intubation, Pediatric
Conditions
Keywords
Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
Brief summary
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.
Detailed description
Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.
Interventions
DEVICEVideo Laryngoscopy
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Need general anesthesia for pyloromyotomy procedure * Have been informed of the nature of the study and informed consent has been obtained from the legally responsible guardian
Exclusion criteria
* Abnormal/difficult airway * Allergy to succinylcholine and/or propofol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Desaturation Below 80% During Intubation | During intubation attempt (less than two minutes) | Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope |
Countries
United States
Participant flow
Recruitment details
4/19/17-7/12/22 pediatric hospital infants \<6m with pyloric stenosis
Participants by arm
| Arm | Count |
|---|---|
| Conventional Direct Laryngoscopy Endotracheal intubation will be performed by conventional direct laryngoscopy. | 30 |
| Video Laryngoscopy Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Video Laryngoscopy | 32 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Conventional Direct Laryngoscopy | Video Laryngoscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 32 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Pyloric Stenosis | 30 Participants | 32 Participants | 62 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 6 / 30 | 4 / 32 |
Outcome results
Primary
Number of Participants Who Had Desaturation Below 80% During Intubation
Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope
Time frame: During intubation attempt (less than two minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Direct Laryngoscopy | Number of Participants Who Had Desaturation Below 80% During Intubation | 6 Participants |
| Video Laryngoscopy | Number of Participants Who Had Desaturation Below 80% During Intubation | 4 Participants |