Clinical trial NCT03779984: Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients
Official title: Use of a Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2018-12-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants With Nasal Bleeding
timeFrame: Within 5 minutes following the nasal tracheal intubation
Secondary outcomes:
measure: The Number of Participants With Severe Epistaxis
timeFrame: Within 5 minutes following nasal intubation
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Heath Hospital System
state: Texas
city: Houston
country: United States
facility: MD Anderson Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Christina Riccio, MD
role: STUDY_DIRECTOR
References: