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Change in staffing structure, no longer fit original study design
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Direct Laryngoscopy | No Intervention | Endotracheal intubation will be performed by conventional direct laryngoscopy. | |
| Video Laryngoscopy | Active Comparator | Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During intubation attempt (less than two minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Horn, MD | Sponsor-Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
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4/19/17-7/12/22 pediatric hospital infants <6m with pyloric stenosis
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Direct Laryngoscopy | Endotracheal intubation will be performed by conventional direct laryngoscopy. |
| FG001 | Video Laryngoscopy | Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Video Laryngoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
<6m of age with pyloric stenosis
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Direct Laryngoscopy | Endotracheal intubation will be performed by conventional direct laryngoscopy. |
| BG001 | Video Laryngoscopy | Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Video Laryngoscopy |
| 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 | 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 | Posted | Count of Participants | Participants | During intubation attempt (less than two minutes) |
|
Adverse event data was collected per patient from intubation through recovery period, a time frame of 24 hours
Adverse event was defined as desaturation below 80% during intubation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Direct Laryngoscopy | Endotracheal intubation will be performed by conventional direct laryngoscopy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| desaturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | desaturation below 80% during intubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nicole Horn | Riley Hospital for Children at Indiana University Health | 3179449981 | nhorn@iuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | Oct 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2018 | Jun 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Sex/Gender were not collected from any participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pyloric Stenosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 30 |
| 6 |
| 30 |
| 0 |
| 30 |
| EG001 | Video Laryngoscopy | Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. | 0 | 32 | 4 | 32 | 0 | 32 |
|
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