Nasal Intubation Using a Parker Flex-tip Endotracheal Tube Compared to a Nasal RAE Tube

NCT02315677 | Completed DMC

• 1 other identifier: H14-02597
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the degree of epistaxis following nasal intubation with either a nasal endotracheal (RAE) tube with bevel facing left or Parker Flex-Tip endotracheal tube with bevel facing posteriorly The investigators hypothesize that a Parker Flex-Tip endotracheal tube when inserted with bevel facing posteriorly during nasal intubation may reduce the incidence of epistaxis intra and post-operatively. The investigators propose that using this style of endotracheal tube improves patient safety and comfort and facilitates ease and success of nasal intubation.

Conditions

Epistaxis

Keywords

Epistaxis; Nasal Intubation; Maxillofacial surgery

Outcome Measures

Primary Outcomes (2)

• Reduced Epistaxis

  The degree of epistaxis will be assessed by a blinded independent investigator immediately post intubation, and along with ease of insertion, recorded. Quantity of epistaxis will be measured by swabbing the nasopharynx with a dry swab and measuring the difference in weight gain between the dry swab and blood soaked swab. Epistaxis will be evaluated based on the criteria established by Sugiyama et al. Four grades will be used: 1. No epistaxis, no blood observed on either the surface of the tube or the posterior pharyngeal wall 2. Mild epistaxis with blood apparent on the surface of the tube or posterior pharyngeal wall 3. Moderate epistaxis with pooling of blood on the posterior pharyngeal wall 4. Severe epistaxis with a large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation

  Immediately post intubation

• Reduced Epistaxis

  The degree of epistaxis will be assessed by a blinded independent investigator 5 minutes post intubation, and along with ease of insertion, recorded. Quantity of epistaxis will be measured by swabbing the nasopharynx with a dry swab and measuring the difference in weight gain between the dry swab and blood soaked swab. Epistaxis will be evaluated based on the criteria established by Sugiyama et al. Four grades will be used: 1. No epistaxis, no blood observed on either the surface of the tube or the posterior pharyngeal wall 2. Mild epistaxis with blood apparent on the surface of the tube or posterior pharyngeal wall 3. Moderate epistaxis with pooling of blood on the posterior pharyngeal wall 4. Severe epistaxis with a large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation

  5 minutes post intubation

Secondary Outcomes (3)

• Ease of tube insertion

  Immediately post intubation

• Number of attempts to insert tube

  Immediately post intubation

• Post-operative patient nasal pain

  Within 2 hours after extubation

Study Arms (2)

Nasal intubation-Standard RAE ETT

ACTIVE COMPARATOR

This arm will receive nasal intubation with the standard RAE endotracheal tube with bevel facing left.

Device: Nasal Intubation with nasal RAE endotracheal tube; Device: Nasal Intubation with Parker Flex-Tip endotracheal tube

Nasal intubation-Parker Flex-Tip ETT

ACTIVE COMPARATOR

This arm will receive nasal intubation with the Parker Flex-tip ETT with bevel facing posteriorly.

Device: Nasal Intubation with nasal RAE endotracheal tube; Device: Nasal Intubation with Parker Flex-Tip endotracheal tube

Interventions

Nasal Intubation with nasal RAE endotracheal tube DEVICE

A single experienced operator with at least 5 years of clinical anesthetic experience will intubate using the standard nasal RAE endotracheal tube with bevel facing leftward.

Nasal intubation-Parker Flex-Tip ETT; Nasal intubation-Standard RAE ETT

Nasal Intubation with Parker Flex-Tip endotracheal tube DEVICE

A single experienced operator with at least 5 years of clinical anesthetic experience will intubate using the Parker Flex-Tip endotracheal tube with the bevel facing posteriorly.

Nasal intubation-Parker Flex-Tip ETT; Nasal intubation-Standard RAE ETT

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients
• Over 16 years of age. The investigators definitely do not want to recruit anyone under age 16 yr
• Undergoing an oral or maxillofacial surgery where nasal intubation would be appropriate for surgical anesthesia
• General anesthesia and nasal intubation discussed and planned in the preoperative assessment clinic
• ASA physical status I or II patients undergoing oral or maxillofacial surgery where nasal intubation would be appropriate for surgical anesthesia.
• ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease ASA Physical Status 4 - A patient with severe systemic disease that is a constant threat to life ASA Physical Status 5 - A moribund patient who is not expected to survive without the operation

You may not qualify if:

• Patients not clinically amenable to general anesthesia
• Documented anatomical deformities in the region of interest which includes nasal passages, internal nasal turbinates and nasopharynx. These structures will henceforth be called"region of interest."
• History of trauma in the region of interest
• Previous surgery in the region of interest
• Coagulation defects
• Anticoagulant medication other than Low Dose Aspirin
• History of recurrent epistaxis
• Age less than 16 years.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Department of Anesthesiology, Pharmacology and Therapeutics

Vancouver, British Columbia, V6Z 1L8, Canada

Location

Related Publications (13)

• Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.

  PMID: 16527796 BACKGROUND

• Chin KJ, Perlas A. Ultrasonography of the lumbar spine for neuraxial and lumbar plexus blocks. Curr Opin Anaesthesiol. 2011 Oct;24(5):567-72. doi: 10.1097/ACO.0b013e32834aa234.

  PMID: 21822134 BACKGROUND

• Hall CE, Shutt LE. Nasotracheal intubation for head and neck surgery. Anaesthesia. 2003 Mar;58(3):249-56. doi: 10.1046/j.1365-2044.2003.03034.x.

  PMID: 12603455 BACKGROUND

• Williams AR, Burt N, Warren T. Accidental middle turbinectomy: a complication of nasal intubation. Anesthesiology. 1999 Jun;90(6):1782-4. doi: 10.1097/00000542-199906000-00039. No abstract available.

  PMID: 10360881 BACKGROUND

• Dost P, Armbruster W. Nasal turbinate dislocation caused by nasotracheal intubation. Acta Anaesthesiol Scand. 1997 Jun;41(6):795-6. doi: 10.1111/j.1399-6576.1997.tb04787.x.

  PMID: 9241346 BACKGROUND

• Tintinalli JE, Claffey J. Complications of nasotracheal intubation. Ann Emerg Med. 1981 Mar;10(3):142-4. doi: 10.1016/s0196-0644(81)80379-4.

  PMID: 7469154 BACKGROUND

• Dinner M, Tjeuw M, Artusio JF Jr. Bacteremia as a complication of nasotracheal intubation. Anesth Analg. 1987 May;66(5):460-2. doi: 10.1213/00000539-198705000-00017. No abstract available.

  PMID: 3578854 BACKGROUND

• O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.

  PMID: 8686823 BACKGROUND

• Sugiyama K, Manabe Y, Kohjitani A. A styletted tracheal tube with a posterior-facing bevel reduces epistaxis during nasal intubation: a randomized trial. Can J Anaesth. 2014 May;61(5):417-22. doi: 10.1007/s12630-014-0156-3. Epub 2014 Mar 28.

  PMID: 24740408 BACKGROUND

• Seo KS, Kim JH, Yang SM, Kim HJ, Bahk JH, Yum KW. A new technique to reduce epistaxis and enhance navigability during nasotracheal intubation. Anesth Analg. 2007 Nov;105(5):1420-4, table of contents. doi: 10.1213/01.ane.0000281156.64133.bd.

  PMID: 17959976 BACKGROUND

• Watt S, Pickhardt D, Lerman J, Armstrong J, Creighton PR, Feldman L. Telescoping tracheal tubes into catheters minimizes epistaxis during nasotracheal intubation in children. Anesthesiology. 2007 Feb;106(2):238-42. doi: 10.1097/00000542-200702000-00010.

  PMID: 17264716 BACKGROUND

• Kim YC, Lee SH, Noh GJ, Cho SY, Yeom JH, Shin WJ, Lee DH, Ryu JS, Park YS, Cha KJ, Lee SC. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesth Analg. 2000 Sep;91(3):698-701. doi: 10.1097/00000539-200009000-00038.

  PMID: 10960403 BACKGROUND

• Earle R, Shanahan E, Vaghadia H, Sawka A, Tang R. Epistaxis during nasotracheal intubation: a randomized trial of the Parker Flex-Tip nasal endotracheal tube with a posterior facing bevel versus a standard nasal RAE endotracheal tube. Can J Anaesth. 2017 Apr;64(4):370-375. doi: 10.1007/s12630-017-0813-4. Epub 2017 Jan 11.

  PMID: 28078544 DERIVED

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Himat Vaghadia, MBBS

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

CA (1)