Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

NCT ID: NCT03779984

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2024-02-01

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.

Conditions

Intubation;Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Red Rubber Catheter

Intervention Type: DEVICE

Experimental group will be intubated with red rubber catheter guidance

Standard nasal tracheal intubation

The nasotracheal tube will be inserted into the nasal passage.

Group Type: SHAM_COMPARATOR

Standard nasal tracheal Intubation

Intervention Type: DEVICE

Control group will be intubated with standard nasal tracheal tube without guidance

Interventions

Red Rubber Catheter

Experimental group will be intubated with red rubber catheter guidance

Intervention Type: DEVICE

Standard nasal tracheal Intubation

Control group will be intubated with standard nasal tracheal tube without guidance

Intervention Type: DEVICE

Other Intervention Names

Nasal tracheal intubation without guidance

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David W Mercier

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Riccio, MD

Role: STUDY_DIRECTOR

UT Southwestern Medical Center

Locations

Parkland Heath Hospital System

Dallas, Texas, United States

MD Anderson Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

STU-2018-0190

Identifier Type: -

Identifier Source: org_study_id