Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

Intubation Complication Clinical Trial

Official title:

Monitoring the Pressure Over Nasotracheal Intubation and Related Nasal Alar Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03735160
• Other study ID #: 18MMHIS084e
• Status: Withdrawn
• Start date: May 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Intubation Complication
• Pressure Injury
• Wounds and Injuries

Intervention

Device:
• pressure sensor
Pressure sensor at the angle of intratracheal tube and nasal alar

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

Al-Metwalli RR, Sadek S. Safety and reliability of the sealing cuff pressure of the Microcuff pediatric tracheal tube for prevention of post-extubation morbidity in children: A comparative study. Saudi J Anaesth. 2014 Oct;8(4):484-8. doi: 10.4103/1658-354 — View Citation

Bernhard WN, Cottrell JE, Sivakumaran C, Patel K, Yost L, Turndorf H. Adjustment of intracuff pressure to prevent aspiration. Anesthesiology. 1979 Apr;50(4):363-6. — View Citation

Bolzan DW, Gomes WJ, Peixoto TC, Faresin SM, Carvalho AC, De Paola AA, Guizilini S. Clinical use of the volume-time curve for endotracheal tube cuff management. Respir Care. 2014 Nov;59(11):1628-35. doi: 10.4187/respcare.02683. Epub 2014 Jun 10. — View Citation

Cherng CH, Chen YW. Using a modified nasotracheal tube to prevent nasal ala pressure sore during prolonged nasotracheal intubation. J Anesth. 2010 Dec;24(6):959-61. doi: 10.1007/s00540-010-1009-z. Epub 2010 Sep 1. — View Citation

Elwany S, Mekhamer A. Effect of nasotracheal intubation on nasal mucociliary clearance. Br J Anaesth. 1987 Jun;59(6):755-9. — View Citation

Holzapfel L. Nasal vs oral intubation. Minerva Anestesiol. 2003 May;69(5):348-52. Review. — View Citation

Huang TT, Tseng CE, Lee TM, Yeh JY, Lai YY. Preventing pressure sores of the nasal ala after nasotracheal tube intubation: from animal model to clinical application. J Oral Maxillofac Surg. 2009 Mar;67(3):543-51. doi: 10.1016/j.joms.2008.06.100. — View Citation

Kuo MJ, Reid AP, Smith JE. Unilateral nasal obstruction: an unusual presentation of a complication of nasotracheal intubation. J Laryngol Otol. 1994 Nov;108(11):991-2. — View Citation

Meier R, Sporn P. [Decubitus ulcer prevention in the nasal ala using Silastic foam in nasotracheal intubated patients]. Anaesthesist. 1986 Jan;35(1):49-50. German. — View Citation

Neves-Pinto RM, Carvalho A, Araujo E, Alberto C, Basilio-De-Oliveira, De Carvalho GA. Nasal septum giant pyogenic granuloma after a long lasting nasal intubation: case report. Rhinology. 2005 Mar;43(1):66-9. Review. — View Citation

Sanuki T, Hirokane M, Matsuda Y, Sugioka S, Kotani J. The Parker Flex-Tip tube for nasotracheal intubation: the influence on nasal mucosal trauma. Anaesthesia. 2010 Jan;65(1):8-11. doi: 10.1111/j.1365-2044.2009.06123.x. Epub 2009 Oct 22. — View Citation

Schneider J, Mulale U, Yamout S, Pollard S, Silver P. Impact of monitoring endotracheal tube cuff leak pressure on postextubation stridor in children. J Crit Care. 2016 Dec;36:173-177. doi: 10.1016/j.jcrc.2016.06.033. Epub 2016 Jul 9. — View Citation

Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. — View Citation

Song J. A comparison of the effects of epinephrine and xylometazoline in decreasing nasal bleeding during nasotracheal intubation. J Dent Anesth Pain Med. 2017 Dec;17(4):281-287. doi: 10.17245/jdapm.2017.17.4.281. Epub 2017 Dec 28. — View Citation

Yeom JH, Oh MK, Shin WJ, Ahn DW, Jeon WJ, Cho SY. Randomized comparison of the effectiveness of nasal intubation using a GlideScope video laryngoscope with Magill forceps versus vascular forceps in patients with a normal airway. Can J Anaesth. 2017 Dec;64 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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