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Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

Monitoring the Pressure Over Nasotracheal Intubation and Related Nasal Alar Injury

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03735160
Enrollment
0
Registered
2018-11-08
Start date
2020-05-01
Completion date
2023-12-31
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Pressure Injury

Keywords

Nasotracheal intubation, nasal alar injury

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.

Interventions

DEVICEpressure sensor

Pressure sensor at the angle of intratracheal tube and nasal alar

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
pressure between nose and intratracheal tubeduring intubationpressure between nose and intratracheal tube detected by pressure sensors
appearance of nosefrom induction to one day after surgeryintact or redness ; if redness then, go through NPUAP classification
VASfrom induction to one day after surgeryPatient'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)
NPUAP classificationfrom induction to one day after surgeryThe National Pressure Ulcer Advisory Panel stage

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026