NCT07353255

Brief Summary

Patients having surgery under general anaesthesia require insertion of a breathing tube to keep the airway open. The technique of inserting a breathing tube through the nose into the trachea (airway) is known as nasotracheal intubation. This is the ideal airway for surgical procedures performed inside the mouth, such as complex teeth extractions and operations on the jaw. Traditionally, the breathing tube is initially inserted blindly into the nasal cavity. Then, a video laryngoscope (a camera device) or a direct laryngoscope is used to visualise and guide the passage of tube into the trachea. This approach can be associated with difficulty passing the tube and has a high incidence of nasal trauma and nosebleed. Alternatively, a flexible fibrescope ( flexible camera device) with pre-loaded tracheal tube is passed through the nostril first under vision, gently advanced through the nasal passage and then to the trachea. Once it is correctly placed in the trachea, the breathing tube is railroaded over it. This procedure allows the clinician to visualise the nasal passage and to choose most patent nostril and hence is likely to reduce risk of nosebleed as compared blind passage of tube through the nose. A videolaryngoscope has a camera on the blade that projects the image onto a monitor screen. As this is a rigid device, it can only be inserted through the oral cavity and allows the advancement of tube into the trachea. Both these techniques are currently used in the clinical practice. However, there are no studies to inform anaesthetists whether there are any differences in the incidence of nosebleed. The investigators therefore wish to do a randomised comparison between flexible fibrescope and videolaryngocope to assess if use of the former is associated with any reduced risk or severity of nosebleed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

June 15, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

January 13, 2026

Last Update Submit

June 11, 2026

Conditions

No Disease

Outcome Measures

Primary Outcomes (1)

  • Nasal trauma score

    a score of 0 to 3 will be provided no bleeding, moderate bleeding, or severe bleeding

    5 minutes from nasotracheal intubation

Secondary Outcomes (6)

  • nasal intubation smoothness score

    During nasotracheal Intubation

  • Total intubation time

    During nasotracheal intubation

  • Laryngoscopy time

    During nasotracheal intubation

  • incidence of post operative sore throat

    Between 3 to 24 hours after intervention (nasotracheal intubation)

  • incidence of postoperative nasal discomfort

    Between 3 to 24 hours after intervention (nasotracheal intubation)

  • +1 more secondary outcomes

Study Arms (2)

Flexible Fibrescope

ACTIVE COMPARATOR

Randomly allocated to have intubation using flexible fibrescope

Device: Nasotracheal Intubation with Fibrescope

Videolarygoscope

ACTIVE COMPARATOR

randomly allocated to have intubation using videolaryngocope

Procedure: Nasotracheal Intubation with Video laryngoscope

Interventions

Nasotracheal Intubation with FibrescopeDEVICE

Intubation of trachea via nasal route with Fibrescope (11302BDX Flex. Intubation Video Endoscope 4 x 65 Karl Storz)

Flexible Fibrescope
Nasotracheal Intubation with Video laryngoscopePROCEDURE

Intubation of trachea via nasal route using a videolaryngoscope (301-000-000 McGRATH™ with Mac Blade)

Videolarygoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and above, presenting for elective surgical procedures and requiring general anaesthesia and nasal intubation will be invited to take part in the study.

You may not qualify if:

  • Patients who do not want to take part or do not give consent
  • Patients unable to give written consent.
  • Patient physical status of ASA 4 and 5,
  • Patients deemed to require awake intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Coventry

Coventry, West Midlands, CV2 2DX, United Kingdom

RECRUITING

Related Publications (6)

  • Collins SR, Blank RS. Fiberoptic intubation: an overview and update. Respir Care. 2014 Jun;59(6):865-78; discussion 878-80. doi: 10.4187/respcare.03012.

    PMID: 24891196BACKGROUND

  • Bansal T, Singhal S, Dhingra K. A study to evaluate nasotracheal intubation using Airtraq laryngoscope with a bougie and without a bougie. Indian J Anaesth. 2022 Nov;66(11):757-762. doi: 10.4103/ija.ija_466_22. Epub 2022 Nov 18.

    PMID: 36590192BACKGROUND

  • El-Seify ZA, Khattab AM, Shaaban AA, Metwalli OS, Hassan HE, Ajjoub LF. Xylometazoline pretreatment reduces nasotracheal intubation-related epistaxis in paediatric dental surgery. Br J Anaesth. 2010 Oct;105(4):501-5. doi: 10.1093/bja/aeq205. Epub 2010 Aug 3.

    PMID: 20682569BACKGROUND

  • Kim YC, Lee SH, Noh GJ, Cho SY, Yeom JH, Shin WJ, Lee DH, Ryu JS, Park YS, Cha KJ, Lee SC. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesth Analg. 2000 Sep;91(3):698-701. doi: 10.1097/00000539-200009000-00038.

    PMID: 10960403BACKGROUND

  • Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.

    PMID: 16527796BACKGROUND

  • Abrons RO, Zimmerman MB, El-Hattab YMS. Nasotracheal intubation over a bougie vs. non-bougie intubation: a prospective randomised, controlled trial in older children and adults using videolaryngoscopy. Anaesthesia. 2017 Dec;72(12):1491-1500. doi: 10.1111/anae.14029. Epub 2017 Sep 15.

    PMID: 28921537BACKGROUND

Study Officials

  • Cyprian Mendonca

    University Hopsitals Coventry & Warwickshire NHS Trust

    STUDY DIRECTOR

Central Study Contacts

Charles Pairaudeau, FRCA

CONTACT

+44719121363Charles.Pairaudeau2@uhcw.nhs.uk

Maria Turslove

CONTACT

+442476966053ResearchSponsorship@uhcw.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

June 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

no plan to share IPD

Locations

GB(1)