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

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ClinicalTrials.gov Identifier: NCT02315677
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Epistaxis Device: Nasal Intubation with nasal RAE endotracheal tube Device: Nasal Intubation with Parker Flex-Tip endotracheal tube Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Nasal Intubation Using a Parker Flex-tip Endotracheal Tube With Posteriorly Facing Bevel Compared to a Nasal RAE Tube With Left Facing Bevel: A Randomized Study
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Active Comparator: Nasal intubation-Standard RAE ETT
This arm will receive nasal intubation with the standard RAE endotracheal tube with bevel facing left.
Device: Nasal Intubation with nasal RAE endotracheal tube
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.

Device: Nasal Intubation with Parker Flex-Tip endotracheal tube
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.

Active Comparator: Nasal intubation-Parker Flex-Tip ETT
This arm will receive nasal intubation with the Parker Flex-tip ETT with bevel facing posteriorly.
Device: Nasal Intubation with nasal RAE endotracheal tube
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.

Device: Nasal Intubation with Parker Flex-Tip endotracheal tube
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.




Primary Outcome Measures :
  1. Reduced Epistaxis [ Time Frame: Immediately post intubation ]

    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

  2. Reduced Epistaxis [ Time Frame: 5 minutes post intubation ]

    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


Secondary Outcome Measures :
  1. Ease of tube insertion [ Time Frame: Immediately post intubation ]
    if no resistance of the either endotracheal tube during advancement into the oropharynx is noted it will be defined as "smooth", and will be inserted into the trachea using direct laryngoscopy. In patients assigned to the Parker Flex-Tip endotracheal tube, the stylette will be withdrawn from the tube immediately after the tube passes through the nasopharynx and the tube will then be advanced into the trachea by direct laryngoscopy. If resistance is noted on insertion of either ETT it will be recorded as "impinged" and a mark will be made on the tube corresponding to the depth of insertion into the nostril to allow the distance between the tip of the tube and the mark to be measured. The assessment of the ease of insertion will only be made on the first attempt, with no manipulation applied against resistance.

  2. Number of attempts to insert tube [ Time Frame: Immediately post intubation ]
  3. Post-operative patient nasal pain [ Time Frame: Within 2 hours after extubation ]
    Post-operative patient nasal pain (Visual Analogue Score anchored at 0= no pain & 10= maximum pain) and satisfaction scores. Patients will be monitored for epistaxis immediately post intubation and for up to two hours in the recovery or until patient is deemed suitable for transfer to the ward. No further monitoring required for study purposes thereafter.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315677


Locations
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Canada, British Columbia
University of British Columbia Department of Anesthesiology, Pharmacology and Therapeutics
Vancouver, British Columbia, Canada, V6Z 1L8
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Himat Vaghadia, MBBS Vancouver Coastal Health

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02315677     History of Changes
Other Study ID Numbers: H14-02597
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by University of British Columbia:
Epistaxis
Nasal Intubation
Maxillofacial surgery

Additional relevant MeSH terms:
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Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms