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Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Intubation;Difficult

Treatments

Device: Standard nasal tracheal Intubation
Device: Red Rubber Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03779984
STU-2018-0190

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

112 participants in 2 patient groups

Red Rubber Catheter Group
Experimental group
Description:
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.
Treatment:
Device: Red Rubber Catheter
Standard nasal tracheal intubation
Sham Comparator group
Description:
The nasotracheal tube will be inserted into the nasal passage.
Treatment:
Device: Standard nasal tracheal Intubation

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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