Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

Not Applicable

Completed

• Conditions: Intubation;Difficult
• Interventions: Device: Red Rubber Catheter; Device: Standard nasal tracheal Intubation

• Registration Number: NCT03779984
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-05-31
• Primary Completion: 2023-12-06
• Study Completion: 2024-02-01
• Status Verified: 2024-10
• Results First Submitted: 2024-10-09
• Results First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Age > 18, male and female
• Subjects undergoing surgery requiring NTI
• ASA 1-3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Red Rubber Catheter Group	Red Rubber Catheter	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	Standard nasal tracheal Intubation	The nasotracheal tube will be inserted into the nasal passage.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

MD Anderson Center; 🇺🇸 Houston, Texas, United States

Parkland Heath Hospital System; 🇺🇸 Dallas, Texas, United States