An interventional study of Red Rubber Catheter and Standard nasal tracheal Intubation in Intubation;Difficult, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
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.
University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Red Rubber Catheter
The nasotracheal tube will be inserted into the nasal passage.
Device: Standard nasal tracheal Intubation
Experimental group will be intubated with red rubber catheter guidance
Control group will be intubated with standard nasal tracheal tube without guidance
Also known as: Nasal tracheal intubation without guidance
The Number of Participants With Nasal Bleeding
The number of participants with nasal bleeding within 5 minutes following nasal tube placement.
Time frame: Within 5 minutes following the nasal tracheal intubation
The Number of Participants With Severe Epistaxis
The number of participants with severe epistaxis within 5 minutes following nasal tube placement.
Time frame: Within 5 minutes following nasal intubation
| Milestone | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation |
|---|---|---|
| Started | 56 | 56 |
| Completed | 56 | 56 |
| Not completed | 0 | 0 |
The number of participants with nasal bleeding within 5 minutes following nasal tube placement.
| Participants | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation |
|---|---|---|
| The Number of Participants With Nasal Bleeding | 22 | 35 |
The number of participants with severe epistaxis within 5 minutes following nasal tube placement.
| Participants | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation |
|---|---|---|
| The Number of Participants With Severe Epistaxis | 1 | 1 |
Collected over Post-operative 24 hrs.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Red Rubber Catheter Group | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Standard Nasal Tracheal Intubation | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
A total of 112 participants enrolled to the study.
| Age, Continuous(years) | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| Mean | 57.37 ± 16.50 | 56.75 ± 16.26 | 57.06 ± 16.31 |
| Sex: Female, Male(Participants) | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 35 | 34 | 69 |
| Race and Ethnicity Not Collected(Participants) | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| United States | 56 | 56 | 112 |
| Body Mass Index (BMI)(Kg/m2) | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| Mean | 27.28 ± 5.01 | 26.33 ± 4.90 | 26.81 ± 4.95 |
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University of Texas Southwestern Medical Center