Intubation;Difficult
Conditions
Brief summary
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.
Detailed description
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 - 1. No epistaxis (no blood observed on either the surface of the tube or the posterior pharyngeal wall); 2. Mild epistaxis (blood apparent on the surface of the tube or posterior pharyngeal wall); 3. Moderate epistaxis (pooling of blood on the posterior pharyngeal wall); 4. Severe epistaxis (a large amount of blood in the pharynx impeding nasotracheal intubation-before the epistaxis assessor enters the operating room, requiring suction for intubation or necessitating urgent orotracheal intubation.) 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.
Interventions
DEVICERed Rubber Catheter
Experimental group will be intubated with red rubber catheter guidance
DEVICEStandard nasal tracheal Intubation
Control group will be intubated with standard nasal tracheal tube without guidance
Sponsors
M.D. Anderson Cancer Center
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome accessor and participants are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18, male and female * Subjects undergoing surgery requiring NTI * ASA 1-3
Exclusion criteria
* History of anticoagulant use or coagulopathy * History of latex allergy * History of difficult airway * Anticipated difficult airway requiring awake intubation * Abnormal anatomy of the nasal passage (due to prior trauma, surgery, congenital defects, etc.) or basilar skull fracture * Patients unable to be placed in the sniffing position * Morbid obesity with BMI \> 40 * Pregnancy * ASA 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Nasal Bleeding | Within 5 minutes following the nasal tracheal intubation | The number of participants with nasal bleeding within 5 minutes following nasal tube placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Severe Epistaxis | Within 5 minutes following nasal intubation | The number of participants with severe epistaxis within 5 minutes following nasal tube placement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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 | 56 |
| Total | 112 |
Baseline characteristics
| Characteristic | Red Rubber Catheter Group | Standard Nasal Tracheal Intubation | Total |
|---|---|---|---|
| Age, Continuous | 57.37 years STANDARD_DEVIATION 16.5 | 56.75 years STANDARD_DEVIATION 16.26 | 57.06 years STANDARD_DEVIATION 16.31 |
| Body Mass Index (BMI) | 27.28 Kg/m2 STANDARD_DEVIATION 5.01 | 26.33 Kg/m2 STANDARD_DEVIATION 4.9 | 26.81 Kg/m2 STANDARD_DEVIATION 4.95 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 56 participants | 56 participants | 112 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 35 Participants | 34 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Red Rubber Catheter Group | The Number of Participants With Nasal Bleeding | 22 Participants |
| Standard Nasal Tracheal Intubation | The Number of Participants With Nasal Bleeding | 35 Participants |
Secondary
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
Population: The number of patients with severe epistaxis in the use of the red rubber catheter vs. the standard insertion catheter
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Red Rubber Catheter Group | The Number of Participants With Severe Epistaxis | 1 Participants |
| Standard Nasal Tracheal Intubation | The Number of Participants With Severe Epistaxis | 1 Participants |