Skip to main content
Clinical Trials/NCT03735160
NCT03735160
Withdrawn
Not Applicable

Monitoring the Pressure Over Nasotracheal Intubation and Related Nasal Alar Injury

Mackay Memorial Hospital1 site in 1 countryMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation Complication
Sponsor
Mackay Memorial Hospital
Locations
1
Primary Endpoint
pressure between nose and intratracheal tube
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chien-Chung,Huang

Principal Investigator,Attending physician of anesthesiology

Mackay Memorial Hospital

Eligibility 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

Outcomes

Primary Outcomes

pressure between nose and intratracheal tube

Time Frame: during intubation

pressure between nose and intratracheal tube detected by pressure sensors

appearance of nose

Time Frame: from induction to one day after surgery

intact or redness ; if redness then, go through NPUAP classification

NPUAP classification

Time Frame: from induction to one day after surgery

The National Pressure Ulcer Advisory Panel stage

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)

Study Sites (1)

Loading locations...

Similar Trials