Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

June 3, 2020 updated by: Chien-Chung,Huang, Mackay Memorial Hospital

Monitoring the Pressure Over Nasotracheal Intubation and Related Nasal Alar Injury

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergo general anesthesia and receive intratracheal intubation through nose

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appearance of nose
Time Frame: from induction to one day after surgery
intact or redness ; if redness then, go through NPUAP classification
from induction to one day after surgery
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)
from induction to one day after surgery
pressure between nose and intratracheal tube
Time Frame: during intubation
pressure between nose and intratracheal tube detected by pressure sensors
during intubation
NPUAP classification
Time Frame: from induction to one day after surgery
The National Pressure Ulcer Advisory Panel stage
from induction to one day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (ACTUAL)

November 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18MMHIS084e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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