CClinicalTrials.gg
CompletedNCT03779984Updated Nov 21, 2024Results posted

Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

An interventional study of Red Rubber Catheter and Standard nasal tracheal Intubation in Intubation;Difficult, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intubation;Difficult
03

In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • 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

  • Sham comparator
    Standard nasal tracheal intubation

    The nasotracheal tube will be inserted into the nasal passage.

    Device: Standard nasal tracheal Intubation

Interventions

  • DeviceRed Rubber Catheter

    Experimental group will be intubated with red rubber catheter guidance

  • DeviceStandard nasal tracheal Intubation

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

    Also known as: Nasal tracheal intubation without guidance

06

What researchers measure

Primary outcomes

  1. The Number of Participants With Nasal Bleeding

    The number of participants with nasal bleeding within 5 minutes following nasal tube placement.

    Time frame: Within 5 minutes following the nasal tracheal intubation

Secondary outcomes

  1. The Number of Participants With Severe Epistaxis

    The number of participants with severe epistaxis within 5 minutes following nasal tube placement.

    Time frame: Within 5 minutes following nasal intubation

07

Results

Posted Nov 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneRed Rubber Catheter GroupStandard Nasal Tracheal Intubation
Started5656
Completed5656
Not completed00

Outcome measures

PrimaryThe Number of Participants With Nasal Bleeding

The number of participants with nasal bleeding within 5 minutes following nasal tube placement.

Time frame:
Within 5 minutes following the nasal tracheal intubation
Reported as:
Count of participants · Participants
The Number of Participants With Nasal Bleeding
ParticipantsRed Rubber Catheter GroupStandard Nasal Tracheal Intubation
The Number of Participants With Nasal Bleeding2235
SecondaryThe Number of Participants With Severe Epistaxis

The number of participants with severe epistaxis within 5 minutes following nasal tube placement.

Time frame:
Within 5 minutes following nasal intubation
Reported as:
Count of participants · Participants
The Number of Participants With Severe Epistaxis
ParticipantsRed Rubber Catheter GroupStandard Nasal Tracheal Intubation
The Number of Participants With Severe Epistaxis11

Adverse events

Collected over Post-operative 24 hrs.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Red Rubber Catheter Group0/56 (0%)0/56 (0%)0/56 (0%)
Standard Nasal Tracheal Intubation0/56 (0%)0/56 (0%)0/56 (0%)

Baseline characteristics

A total of 112 participants enrolled to the study.

Age, Continuous
Age, Continuous(years)Red Rubber Catheter GroupStandard Nasal Tracheal IntubationTotal
Mean57.37 ± 16.5056.75 ± 16.2657.06 ± 16.31
Sex: Female, Male
Sex: Female, Male(Participants)Red Rubber Catheter GroupStandard Nasal Tracheal IntubationTotal
Female212243
Male353469
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Red Rubber Catheter GroupStandard Nasal Tracheal IntubationTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Red Rubber Catheter GroupStandard Nasal Tracheal IntubationTotal
United States5656112
Body Mass Index (BMI)
Body Mass Index (BMI)(Kg/m2)Red Rubber Catheter GroupStandard Nasal Tracheal IntubationTotal
Mean27.28 ± 5.0126.33 ± 4.9026.81 ± 4.95
08

Study locations

2 sites
  • Parkland Heath Hospital System
    Dallas, Texas 75390, United States
  • MD Anderson Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol, analysis plan and consent form · Feb 14, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03779984
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
M.D. Anderson Cancer Center
Responsible party
David W Mercier (Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Dec 19, 2018
Start date
May 31, 2019
Primary completion
Dec 6, 2023
Completion
Feb 1, 2024
Results posted
Nov 21, 2024
Last update
Nov 21, 2024

Study contacts

Christina Riccio, MD
study director · UT Southwestern Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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