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Intubation ComplicationNCT03735160

Pressure Over Nasotracheal Intubation Related Nasal Alar Injury

An observational study of Intubation Complication and Pressure Injury, run by Mackay Memorial Hospital at 1 site in Taiwan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Intubation Complication, Pressure Injury
What is being tested?
pressure sensor
Type of treatment
Medical device
How many people
0 participants
Where
1 siteTaiwan
Study dates
1 May 2020to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients undergo general anesthesia and receive intratracheal intubation through nose

Who may be able to join

  • American Society of Anesthesiologists (ASA) Physical classification I \& II
  • patients undergo general anesthesia and receive intratracheal intubation through nose
  • elective surgery

Who cannot join

  • with known nasal injury
  • already intubation before induction
  • surgery on the nose
  • emergent operation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • MacKay Memorial Hospital

    Taipei, 104

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
pressure sensor
Keywords
Nasotracheal intubation, nasal alar injury
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pressure sensorDevice

    Pressure sensor at the angle of intratracheal tube and nasal alar

Study groups in NCT03735160
Study groupRoleWhat they receive
Nasal intubation with pressure sensoranesthetized patient with nasotracheal intubation
Receives: Device: pressure sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. appearance of nose

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

    Measured: from induction to one day after surgery

  2. 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)

    Measured: from induction to one day after surgery

  3. pressure between nose and intratracheal tube

    pressure between nose and intratracheal tube detected by pressure sensors

    Measured: during intubation

  4. NPUAP classification

    The National Pressure Ulcer Advisory Panel stage

    Measured: from induction to one day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start1 May 2020 (estimated)
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: Technical problem

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735160
Sponsor's protocol ID
18MMHIS084e
Status last verified
Jun 2020
First submitted
6 Nov 2018
Last updated
5 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1136/bmj.288.6422.965.

    PubMed 6423162

  • 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.

    PubMed 27546768

  • 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: 10.4103/1658-354X.140856.

    PubMed 25422605

  • 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.

    PubMed 24917452

  • 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. doi: 10.1097/00000542-197904000-00018. No abstract available.

    PubMed 434545

  • Elwany S, Mekhamer A. Effect of nasotracheal intubation on nasal mucociliary clearance. Br J Anaesth. 1987 Jun;59(6):755-9. doi: 10.1093/bja/59.6.755.

    PubMed 3606919

  • 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.

    PubMed 15844505

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

    PubMed 12768165

  • 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. doi: 10.1017/s0022215100128701.

    PubMed 7829957

  • 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(12):1176-1181. doi: 10.1007/s12630-017-0971-4. Epub 2017 Sep 26.

    PubMed 28952139

  • 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.

    PubMed 19849677

  • 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.

    PubMed 29349350

  • 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.

    PubMed 20809246

  • 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.

    PubMed 19231778

  • 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.

    PubMed 3963354

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation Complication and Pressure Injury, run by Mackay Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

appearance of nose (time frame: from induction to one day after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735160, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.

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