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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. This study will assess if the red-rubber catheter method leads to lower incidence and severity of epistaxis, faster time to intubation, and higher patient satisfaction compared to the current standard of care.
The study population for this prospective randomized controlled trial will consist of male and female adult subjects over the age of 18 having surgery requiring nasal tracheal intubation (NTI). Subjects will be randomized to either the Red Rubber Catheter (RRC) group or control group.
Oxymetazoline nasal spray will be administered with 1 spray per nostril preoperatively. Premedication with glycopyrrolate 0.2 mg and benzodiazepine at discretion of provider will be given preoperatively. Subjects will then be brought into the operating room and placed on all standard ASA monitors (BP cuff, EKG, pulse oximetry). One spray of oxymetazoline per nostril will again be administered. Standard preoxygenation will be used with a face mask and 100% O2. After induction of anesthesia, provider will confirm mask ventilation and 1 more spray of oxymetazoline will be administered per nostril. Intubation will first be attempted via a naris. Size 6.5 nasotracheal RAE tubes (Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, manufactured by Coviden llc, Mansfield, MA 02048) will be used in female patients and size 7.5 in males. The tubes will be thermosoftened by allowing them to sit in warm saline prior to use. Water-based lubrication will be used for dilation and intubation. Time from insertion of RRC or NETT into nasal passage to first recording of end-tidal CO2 will be recorded. Direct video laryngoscopy will be used to facilitate placement of the nasotracheal RAE tube.
Five minutes after intubation, a non-collaborating anesthesia provider blinded to the method of intubation will grade the severity of bleeding by performing direct video laryngoscopy, inspecting the posterior pharynx and using a scale -
Degree of patient satisfaction and nasal pain on the side of intubation will be rated on a numerical rating scale at 30 and 60 minutes in the post-anesthesia care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red Rubber Catheter Group | Experimental | Red Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. |
|
| Standard nasal tracheal intubation | Sham Comparator | The nasotracheal tube will be inserted into the nasal passage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Rubber Catheter | Device | Experimental group will be intubated with red rubber catheter guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Nasal Bleeding | The number of participants with nasal bleeding within 5 minutes following nasal tube placement. | Within 5 minutes following the nasal tracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Severe Epistaxis | The number of participants with severe epistaxis within 5 minutes following nasal tube placement. | Within 5 minutes following nasal intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Riccio, MD | University of Texas Southwestern Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Heath Hospital System | Dallas | Texas | 75390 | United States | ||
| MD Anderson Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Red Rubber Catheter Group | Red Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance |
| FG001 | Standard Nasal Tracheal Intubation | The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 112 participants enrolled to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Red Rubber Catheter Group | Red Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Participants With Nasal Bleeding | The number of participants with nasal bleeding within 5 minutes following nasal tube placement. | Posted | Count of Participants | Participants | Within 5 minutes following the nasal tracheal intubation |
|
Post-operative 24 hrs.
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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 | Red Rubber Catheter Group | Red Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Mercier | UTexasSouthwestern | 214-645-3479 | David.Mercier@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 14, 2022 | Sep 30, 2024 | Prot_SAP_ICF_000.pdf |
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Outcome accessor and participants are blinded.
| Standard nasal tracheal Intubation | Device | Control group will be intubated with standard nasal tracheal tube without guidance |
|
|
| Houston |
| Texas |
| 77030 |
| United States |
| Standard Nasal Tracheal Intubation |
The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
|
|
| Secondary | The Number of Participants With Severe Epistaxis | The number of participants with severe epistaxis within 5 minutes following nasal tube placement. | The number of patients with severe epistaxis in the use of the red rubber catheter vs. the standard insertion catheter | Posted | Count of Participants | Participants | Within 5 minutes following nasal intubation |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Standard Nasal Tracheal Intubation | The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance | 0 | 56 | 0 | 56 | 0 | 56 |
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