Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

Sponsor

Mackay Memorial Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03735160

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MacKay Memorial Hospital	Taipei		Taiwan	104

Sponsors and Collaborators

Mackay Memorial Hospital

Investigators

Study Director: Chien-Chung Huang, MD, Mackay Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 8, 2018

Last Update Posted:

Jun 5, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chien-Chung,Huang, Principal Investigator,Attending physician of anesthesiology, Mackay Memorial Hospital

Nasotracheal intubation

nasal alar injury

Additional relevant MeSH terms:

Wounds and Injuries

Crush Injuries

Study Results

No Results Posted as of Jun 5, 2020