Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735160
Recruitment Status : Withdrawn (Technical problem)
First Posted : November 8, 2018
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Chien-Chung,Huang, Mackay Memorial Hospital

Brief Summary:
Nasotracheal intubation can cause injury and hemorrhage of nasal mucosa and nasal alar. The investigators measure the actual pressure at the angle between nasotracheal tube and nasal alar, analyze the relationship of clinical signs and symptoms to build up optimal clinical routines.

Condition or disease Intervention/treatment
Intubation Complication Pressure Injury Device: pressure sensor

Detailed Description:

While assisting ventilation during general anesthesia or other reasons, patients are often intubated with endotracheal tube to secure airway. Endotracheal tube can be placed trans-orally or trans-nasally according to surgical conditions, anatomical considerations and nursing needs. Except inadequate cuff pressure related complication, nasotracheal intubation can cause dysfunction of nasal mucosal cilia, injury and hemorrhage of nasal mucosa, turbinate avulsion, obstruction of nasal airway, sinusitis and compression and injury of nasal alar, resulting in local erythema, ischemia, pressure sore, necrosis, tissue damage and may affect appearance.

Previous studies focus on the process of nasal tracheal intubation, aim to reduce mucosal injury and hemorrhage via specific intubation tool, special endotracheal tube design, lubricant and so on. However, evidences in preventing nasal alar injury are limited, in which injuries are mostly prevented by self-made special endotracheal tube and artificial leather. In general, the etiology of tissue damage is compression pressure exceeding local capillary perfusion pressure, resulting in reduced perfusion, ischemia and necrosis. Clinically, health providers prevent the injury by standardized endotracheal tube fixation and/or artificial leather at sites with potential compression. But the extend of the effect of endotracheal tube to trachea mucosa varies, range of pressure affecting capillary perfusion pressure are not yet defined, and no routine monitoring for dermis compression. Thus, endotracheal tube related skin damage is an important clinical issue without best standard operating procedure.

In this study, the investigators will place a pressure sensor at the angle of nasotracheal tube, measure the actual pressure, define the sites of compression and its pressure, analyze the relationship of clinical signs and symptoms, pressure, and duration of nasotracheal intubation, and build up optimal clinical routines.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring the Pressure Over Nasotracheal Intubation and Related Nasal Alar Injury
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
Nasal intubation with pressure sensor
anesthetized patient with nasotracheal intubation
Device: pressure sensor
Pressure sensor at the angle of intratracheal tube and nasal alar




Primary Outcome Measures :
  1. appearance of nose [ Time Frame: from induction to one day after surgery ]
    intact or redness ; if redness then, go through NPUAP classification

  2. VAS [ Time Frame: from induction to one day after surgery ]
    Patient's VISUAL ANALOG SCALE (VAS) for pain of the nose after surgery: no pain (0 - 4 mm), mild pain (5- 44mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

  3. pressure between nose and intratracheal tube [ Time Frame: during intubation ]
    pressure between nose and intratracheal tube detected by pressure sensors

  4. NPUAP classification [ Time Frame: from induction to one day after surgery ]
    The National Pressure Ulcer Advisory Panel stage



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergo general anesthesia and receive intratracheal intubation through nose
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical classification I & II
  • patients undergo general anesthesia and receive intratracheal intubation through nose
  • elective surgery

Exclusion Criteria:

  • with known nasal injury
  • already intubation before induction
  • surgery on the nose
  • emergent operation

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): NCT03735160


Locations
Layout table for location information
Taiwan
MacKay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Layout table for investigator information
Study Director: Chien-Chung Huang, MD Mackay Memorial Hospital
Publications of Results:

Layout table for additonal information
Responsible Party: Chien-Chung,Huang, Principal Investigator,Attending physician of anesthesiology, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03735160    
Other Study ID Numbers: 18MMHIS084e
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chien-Chung,Huang, Mackay Memorial Hospital:
Nasotracheal intubation
nasal alar injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Crush Injuries
Wounds and Injuries