Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

Use of a Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: Red Rubber Catheter; Device: Standard nasal tracheal Intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Parkland Heath Hospital System
    • Houston, Texas, United States, 77030
      • MD Anderson Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Red Rubber Catheter; Experimental group will be intubated with red rubber catheter guidance
Sham Comparator: Standard nasal tracheal intubation; The nasotracheal tube will be inserted into the nasal passage.	Device: Standard nasal tracheal Intubation; Control group will be intubated with standard nasal tracheal tube without guidance; Other Names: Nasal tracheal intubation without guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Study Director: Christina Riccio, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STU-2018-0190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes