Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

NCT03779984 | Completed Results DMC FDA Device

• 1 other identifier: STU-2018-0190
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Number of Participants With Severe Epistaxis

  Within 5 minutes following nasal intubation

Study Arms (2)

Red Rubber Catheter Group

EXPERIMENTAL

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

Standard nasal tracheal intubation

SHAM COMPARATOR

The nasotracheal tube will be inserted into the nasal passage.

Device: Standard nasal tracheal Intubation

Interventions

Red Rubber Catheter DEVICE

Experimental group will be intubated with red rubber catheter guidance

Red Rubber Catheter Group

Standard nasal tracheal Intubation DEVICE

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

Also known as: Nasal tracheal intubation without guidance

Standard nasal tracheal intubation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (2)

Parkland Heath Hospital System

Dallas, Texas, 75390, United States

Location

MD Anderson Center

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: David Mercier
• Organization: UTexasSouthwestern

David.Mercier@utsouthwestern.edu

214-645-3479

Study Officials

• Christina Riccio, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome accessor and participants are blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: May 31, 2019
• Primary Completion: December 6, 2023
• Study Completion: February 1, 2024
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)