No DiseaseNCT07353255
Fibrescope vs Videolaryngoscope for Nasotracheal Intubation
A study testing Nasotracheal Intubation with Fibrescope and Nasotracheal Intubation with Video laryngoscope in people with No Disease, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Disease
- What is being tested?
- Nasotracheal Intubation with Fibrescope and Nasotracheal Intubation with Video laryngoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Coventry
Coventry, West Midlands, CV2 2DX
Charles F Pairaudeau, +442476 965874, charles.pairaudeau2@uhcw.nhs.uk
About this study
Official title: Flexible Fibrescope Versus Video Laryngoscope for Nasotracheal Intubation - A Randomised Comparison
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.
Read more
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.
Read the detailed description
Introduction
The technique of inserting a tracheal tube through the nasal passage into the trachea (airway) is known as nasotracheal intubation. This is the preferred airway for surgical procedures performed in and around oral cavity including dental procedures. Traditionally, the tracheal tube is initially inserted blindly into the nasal cavity. A laryngoscope is then used to visualise and help guide the passage of the tube into the trachea. This approach can be associated with difficulty passing the tube and a high incidence of nasal trauma [1, 2], as the nasal passages can be narrow and demonstrate inter-individual anatomic variability.
Various approaches have been described in the literature to reduce nasal trauma including warming the tube [3], applying water-based lubricants and preparing the nasopharynx with progressive dilation and/or a topical vasoconstrictors [4]. There have been randomised studies using curve-tipped suction catheters [2], and bougies [1,5] showing reduced incidence of nasal trauma as compared to blind passage of the tube through the nose. However, as these devices are blindly inserted through the nasal passage, the device itself can cause some degree of trauma.
The investigators hypothesise that the use of the flexible fibrescope could reduce nasal trauma and bleeding whilst improving first time intubation success rates, when compared to video laryngoscope-assisted nasal intubation. Using a fiberscope allows for an assessment of the patency of the nasal passages and visualisation of the path the tube will take through the nasopharynx.
In current practice, both flexible fibrescopes and video laryngoscopes are routinely used for tracheal intubation. However, with video laryngoscopy during nasal intubation, insertion of tube through the nasal passage is blind. Therefore, some practitioners prefer using a fiberscope for nasal intubation. Clinicians are uncertain as to which is the best approach. To our knowledge, previous studies have not utilised flexible fibrescopes to eliminate blind insertion of the tube in the nostril. Comparing the efficacy of a flexible fibrescope with a tracheal tube railroaded over it to a video laryngoscope for nasotracheal intubation could inform airway practitioners on their choice of technique to improve success and minimise bleeding risk.
Methods
On arrival to theatre, following a standard WHO surgical safety check list and application of routine monitoring, patients will be randomly allocated to either flexible fibrescope or video laryngoscope to facilitate nasotracheal intubation. All patients will receive decongestant nasal spray of 5% lidocaine with 0.5% phenylephrine 1 ml in each nostril.
Both a flexible fiberscope and a video laryngoscope will be available in the anaesthetic room prior to revelation of the group.
All other aspects of patient care outside of the randomisation to fibrescope or video laryngoscopy for nasotracheal intubation will be conducted in accordance with routine clinical practice and local guidelines.
For patients randomised to the video laryngoscope, laryngoscopy will be performed using the video laryngoscope: Mcgrath ™ MAC video laryngoscope (Medtronic Plc, Galway Ireland). A lubricated 6.0 mm ID tube: Polar™ Preformed Tracheal tube, North Nasal Profile™ (Smiths Medical ASD, Inc, Minneapolis, USA) will be inserted through the most patent nostril (as identified during preoperative visit) and advanced until it reaches the posterior nares. It will be then advanced through the vocal cords into the trachea under video guidance. If there was any hold-up immediately after passing the tube through the nostrils, the tube will be gently rotated to allow passage through the nasopharynx. If there is any impingement at the level of arytenoids, the tube will be withdrawn slightly, rotated anticlockwise and then advanced.
For patients randomised to the fiberscope, the same tube type will be loaded on the 4mm fibrescope: Flex. Intubation Video Endoscope 4 x 65 - model 11302BDX (Karl Stortz Tuttlingen, Germany) prior to beginning intubation. The fibrescope will then be inserted into the most patent nostril. If this nostril is deemed to be adequate by the operator, the procedure will continue, otherwise the other nostril will be assessed and the most optimal nostril will be chosen for intubation. The fibrescope will be advanced through the nasopharynx and into the trachea. At this point the tube will be advanced over the fiberscope from the trachea.
Correct placement of the tube will be confirmed using end tidal CO2 and once nasotracheal intubation is completed the rest of the anaesthetic management will proceed as planned by the lead anaesthetist.
During nasotracheal intubation the data collected will include severity of nasal trauma on a 4 point scale, smoothness of nasal intubation on a 4 point scale , laryngoscopy time (from insertion of laryngoscope in the mouth to visualize the vocal cords or from insertion of fiberscope in the nostril to visualise the vocal cords), intubation time (time from insertion of fiberscope or video laryngoscope till first capnography trace) and first attempt success rate (% of intubations succeeded in first attempt), number of intubation attempts and any additional manoeuvres required (external pressure on thyroid cartilage, tube rotation, tube impingement).
Follow-up assessments
Patients will be reviewed in the first 3 to 24 hours whilst they are in the hospital, as apart a standard postoperative visit, where an assessment of patient-centred secondary outcomes will be made. No further follow up is required for this study. If any patients report continuing nasal bleed in the postoperative period, a maxillofacial surgeon will be requested to review the patient for further management and any outcome data may be collected up to 72 hours.
Consent
Participants will be given adequate time to read and understand the patient information leaflet. Once they have read the information, any questions will be answered. If they agree for the study, they will be asked to complete the consent form. The consent will be obtained by chief investigator, principal investigator or one of the research team members delegated and supervised by the investigators.
Sample size
Sample size is based on the primary outcome of incidence of nasal bleeding. A previous study of video laryngoscope assisted nasotracheal intubation reported a rate of bleeding detected in the posterior pharynx of 68% (Abrons 2017). A relative reduction in 33% is considered clinically significant. To detect this treatment difference at a significant level of 5% and power of 90%, a total sample of 186 patients is required. To account for failure and loss of follow up, the investigators will recruit a total of 200 patients.
Randomisation Methodology
Participants will be randomised using a paper randomisation list that will be provided to the UHCW Research and Development (R\&D) department, independent from the rest of the study team. The randomisation list will be generated by the study statistician prior to recruitment starting. The method of permuted random blocks will be utilised, with varying block sizes used.
Blinding
It will not be possible to blind the investigator to the type of device used. However, 5 minutes after completion of intubation, the operating surgeon (who is blinded to the technique of intubation) will examine the oropharynx and record the bleeding. At the time of intubation, the investigator will record the bleeding as seen on video laryngoscope or fiberscope monitor screen.
Assessment and management of risk
For this study, patients requiring general anaesthesia and nasotracheal intubation for elective surgical procedures will be recruited. The flexible fibrescope and video laryngoscope selected for this study are currently used in routine clinical practice as intubation aids. In the event of any unanticipated difficulty with intubation, the lead anaesthetist will follow the Difficult Airway Society guidelines and data collection will stop at this point.
The lead anaesthetist is free to choose different airway equipment to those specified by the study if they feel that this would be clinically appropriate. The investigators do not anticipate any additional risks to the study participants. During the procedure of airway management, all patients will be closely monitored as specified by 'Association of Anaesthetists' standards of monitoring during anaesthesia. This includes peripheral oxygen saturation, end tidal oxygen, depth of anaesthesia and end-tidal CO2, ECG and blood pressure.
References
- Abrons RO, Zimmerman MB, El-Hattab YMS. Nasotracheal intubation over a bougie vs. non-bougieintubation: a prospective randomised, controlled trial in older children and adults usingvideolaryngoscopy. Anaesthesia 2017; 72: 1491-500.
- Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotra- cheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Canadian Journal of Anesthesia 2006; 53: 295-8
- Kim YC, Lee SH, Noh GJ, et al. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesthesia and Analgesia 2000; 91: 698- 701.
- El-Seify ZA, Khattab AM, Shaaban AA, Metwalli OS, Hassan HE, Ajjoub LF. Xylometazoline pretreatment reduces nasotra- cheal intubation-related epistaxis in paediatric dental surgery. British Journal of Anaesthesia 2010; 105: 501-5.
- 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;66:757-62.
- 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: 24891196.
- Hansel, J., Roger, A.M., et al. (2022) Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation, Cochrane Database of Systematic Reviews, 4(4), CD011136. Available at https://pubmed.ncbi.nlm.nih.gov/35373840/ (Accessed 5 July 2023)
- Conditions
- No Disease
- Being tested
- Nasotracheal Intubation with Fibrescope, Nasotracheal Intubation with Video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasotracheal Intubation with FibrescopeDevice
Intubation of trachea via nasal route with Fibrescope (11302BDX Flex. Intubation Video Endoscope 4 x 65 Karl Storz)
Nasotracheal Intubation with Video laryngoscopeProcedure or surgery
Intubation of trachea via nasal route using a videolaryngoscope (301-000-000 McGRATH™ with Mac Blade)
| Study group | Role | What they receive |
|---|---|---|
| Flexible Fibrescope | Active comparator | Randomly allocated to have intubation using flexible fibrescope Receives: Device: Nasotracheal Intubation with Fibrescope |
| Videolarygoscope | Active comparator | randomly allocated to have intubation using videolaryngocope Receives: Procedure: Nasotracheal Intubation with Video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal trauma score
a score of 0 to 3 will be provided no bleeding, moderate bleeding, or severe bleeding
Measured: 5 minutes from nasotracheal intubation
Secondary outcomes (6)
nasal intubation smoothness score
A score of 0 to 3 being given; smooth insertion (0), slight resistance, insertion with great resistance and not possible to insert requiring change of nostril
Measured: During nasotracheal Intubation
Total intubation time
time in seconds from insertion of fiberscope or video laryngoscope till first capnography trace
Measured: During nasotracheal intubation
Laryngoscopy time
time in seconds from insertion of laryngoscope in the mouth to visualize the vocal cords or from insertion of fiberscope in the nostril to visualise the vocal cords
Measured: During nasotracheal intubation
incidence of post operative sore throat
Number of patients having soret throat in the post operative period
Measured: Between 3 to 24 hours after intervention (nasotracheal intubation)
incidence of postoperative nasal discomfort
number of patients having nasal discomfort in the postoperative period
Measured: Between 3 to 24 hours after intervention (nasotracheal intubation)
Incidence of post operative nasal bleeding or blood stained discharge
number of patients having nasal discomfort in the postoperative period
Measured: Between 3 to 24 hours after intervention (nasotracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for No DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyprian Mendonca, Study director, University Hopsitals Coventry & Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353255
- Sponsor's protocol ID
- 343162
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Publications
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.
PubMed 24891196Bansal 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.
PubMed 36590192El-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.
PubMed 20682569Kim 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.
PubMed 10960403Morimoto 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.
PubMed 16527796Abrons 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.
PubMed 28921537
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Fibrescope Versus Video Laryngoscope for Nasotracheal Intubation - A Randomised Comparison
- ClinicalTrials.gov ID
- NCT07353255
- Acronym / sponsor ID
- 343162
- Conditions
- No Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction
The technique of inserting a tracheal tube through the nasal passage into the trachea (airway) is known as nasotracheal intubation. This is the preferred airway for surgical procedures performed in and around oral cavity including dental procedures. Traditionally, the tracheal tube is initially inserted blindly into the nasal cavity. A laryngoscope is then used to visualise and help guide the passage of the tube into the trachea. This approach can be associated with difficulty passing the tube and a high incidence of nasal trauma [1, 2], as the nasal passages can be narrow and demonstrate inter-individual anatomic variability.
Various approaches have been described in the literature to reduce nasal trauma including warming the tube [3], applying water-based lubricants and preparing the nasopharynx with progressive dilation and/or a topical vasoconstrictors [4]. There have been randomised studies using curve-tipped suction catheters [2], and bougies [1,5] showing reduced incidence of nasal trauma as compared to blind passage of the tube through the nose. However, as these devices are blindly inserted through the nasal passage, the device itself can cause some degree of trauma.
The investigators hypothesise that the use of the flexible fibrescope could reduce nasal trauma and bleeding whilst improving first time intubation success rates, when compared to video laryngoscope-assisted nasal intubation. Using a fiberscope allows for an assessment of the patency of the nasal passages and visualisation of the path the tube will take through the nasopharynx.
In current practice, both flexible fibrescopes and video laryngoscopes are routinely used for tracheal intubation. However, with video laryngoscopy during nasal intubation, insertion of tube through the nasal passage is blind. Therefore, some practitioners prefer using a fiberscope for nasal intubation. Clinicians are uncertain as to which is the best approach. To our knowledge, previous studies have not utilised flexible fibrescopes to eliminate blind insertion of the tube in the nostril. Comparing the efficacy of a flexible fibrescope with a tracheal tube railroaded over it to a video laryngoscope for nasotracheal intubation could inform airway practitioners on their choice of technique to improve success and minimise bleeding risk.
Methods
On arrival to theatre, following a standard WHO surgical safety check list and application of routine monitoring, patients will be randomly allocated to either flexible fibrescope or video laryngoscope to facilitate nasotracheal intubation. All patients will receive decongestant nasal spray of 5% lidocaine with 0.5% phenylephrine 1 ml in each nostril.
Both a flexible fiberscope and a video laryngoscope will be available in the anaesthetic room prior to revelation of the group.
All other aspects of patient care outside of the randomisation to fibrescope or video laryngoscopy for nasotracheal intubation will be conducted in accordance with routine clinical practice and local guidelines.
For patients randomised to the video laryngoscope, laryngoscopy will be performed using the video laryngoscope: Mcgrath ™ MAC video laryngoscope (Medtronic Plc, Galway Ireland). A lubricated 6.0 mm ID tube: Polar™ Preformed Tracheal tube, North Nasal Profile™ (Smiths Medical ASD, Inc, Minneapolis, USA) will be inserted through the most patent nostril (as identified during preoperative visit) and advanced until it reaches the posterior nares. It will be then advanced through the vocal cords into the trachea under video guidance. If there was any hold-up immediately after passing the tube through the nostrils, the tube will be gently rotated to allow passage through the nasopharynx. If there is any impingement at the level of arytenoids, the tube will be withdrawn slightly, rotated anticlockwise and then advanced.
For patients randomised to the fiberscope, the same tube type will be loaded on the 4mm fibrescope: Flex. Intubation Video Endoscope 4 x 65 - model 11302BDX (Karl Stortz Tuttlingen, Germany) prior to beginning intubation. The fibrescope will then be inserted into the most patent nostril. If this nostril is deemed to be adequate by the operator, the procedure will continue, otherwise the other nostril will be assessed and the most optimal nostril will be chosen for intubation. The fibrescope will be advanced through the nasopharynx and into the trachea. At this point the tube will be advanced over the fiberscope from the trachea.
Correct placement of the tube will be confirmed using end tidal CO2 and once nasotracheal intubation is completed the rest of the anaesthetic management will proceed as planned by the lead anaesthetist.
During nasotracheal intubation the data collected will include severity of nasal trauma on a 4 point scale, smoothness of nasal intubation on a 4 point scale , laryngoscopy time (from insertion of laryngoscope in the mouth to visualize the vocal cords or from insertion of fiberscope in the nostril to visualise the vocal cords), intubation time (time from insertion of fiberscope or video laryngoscope till first capnography trace) and first attempt success rate (% of intubations succeeded in first attempt), number of intubation attempts and any additional manoeuvres required (external pressure on thyroid cartilage, tube rotation, tube impingement).
Follow-up assessments
Patients will be reviewed in the first 3 to 24 hours whilst they are in the hospital, as apart a standard postoperative visit, where an assessment of patient-centred secondary outcomes will be made. No further follow up is required for this study. If any patients report continuing nasal bleed in the postoperative period, a maxillofacial surgeon will be requested to review the patient for further management and any outcome data may be collected up to 72 hours.
Consent
Participants will be given adequate time to read and understand the patient information leaflet. Once they have read the information, any questions will be answered. If they agree for the study, they will be asked to complete the consent form. The consent will be obtained by chief investigator, principal investigator or one of the research team members delegated and supervised by the investigators.
Sample size
Sample size is based on the primary outcome of incidence of nasal bleeding. A previous study of video laryngoscope assisted nasotracheal intubation reported a rate of bleeding detected in the posterior pharynx of 68% (Abrons 2017). A relative reduction in 33% is considered clinically significant. To detect this treatment difference at a significant level of 5% and power of 90%, a total sample of 186 patients is required. To account for failure and loss of follow up, the investigators will recruit a total of 200 patients.
Randomisation Methodology
Participants will be randomised using a paper randomisation list that will be provided to the UHCW Research and Development (R\&D) department, independent from the rest of the study team. The randomisation list will be generated by the study statistician prior to recruitment starting. The method of permuted random blocks will be utilised, with varying block sizes used.
Blinding
It will not be possible to blind the investigator to the type of device used. However, 5 minutes after completion of intubation, the operating surgeon (who is blinded to the technique of intubation) will examine the oropharynx and record the bleeding. At the time of intubation, the investigator will record the bleeding as seen on video laryngoscope or fiberscope monitor screen.
Assessment and management of risk
For this study, patients requiring general anaesthesia and nasotracheal intubation for elective surgical procedures will be recruited. The flexible fibrescope and video laryngoscope selected for this study are currently used in routine clinical practice as intubation aids. In the event of any unanticipated difficulty with intubation, the lead anaesthetist will follow the Difficult Airway Society guidelines and data collection will stop at this point.
The lead anaesthetist is free to choose different airway equipment to those specified by the study if they feel that this would be clinically appropriate. The investigators do not anticipate any additional risks to the study participants. During the procedure of airway management, all patients will be closely monitored as specified by 'Association of Anaesthetists' standards of monitoring during anaesthesia. This includes peripheral oxygen saturation, end tidal oxygen, depth of anaesthesia and end-tidal CO2, ECG and blood pressure.
References
- Abrons RO, Zimmerman MB, El-Hattab YMS. Nasotracheal intubation over a bougie vs. non-bougieintubation: a prospective randomised, controlled trial in older children and adults usingvideolaryngoscopy. Anaesthesia 2017; 72: 1491-500.
- Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotra- cheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Canadian Journal of Anesthesia 2006; 53: 295-8
- Kim YC, Lee SH, Noh GJ, et al. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesthesia and Analgesia 2000; 91: 698- 701.
- El-Seify ZA, Khattab AM, Shaaban AA, Metwalli OS, Hassan HE, Ajjoub LF. Xylometazoline pretreatment reduces nasotra- cheal intubation-related epistaxis in paediatric dental surgery. British Journal of Anaesthesia 2010; 105: 501-5.
- 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;66:757-62.
- 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: 24891196.
- Hansel, J., Roger, A.M., et al. (2022) Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation, Cochrane Database of Systematic Reviews, 4(4), CD011136. Available at https://pubmed.ncbi.nlm.nih.gov/35373840/ (Accessed 5 July 2023)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Fibrescope | Active comparator | Device: Nasotracheal Intubation with FibrescopeRandomly allocated to have intubation using flexible fibrescope |
| Videolarygoscope | Active comparator | Procedure: Nasotracheal Intubation with Video laryngoscoperandomly allocated to have intubation using videolaryngocope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasotracheal Intubation with FibrescopeIntubation of trachea via nasal route with Fibrescope (11302BDX Flex. Intubation Video Endoscope 4 x 65 Karl Storz) | Device | Flexible Fibrescope |
| Nasotracheal Intubation with Video laryngoscopeIntubation of trachea via nasal route using a videolaryngoscope (301-000-000 McGRATH™ with Mac Blade) | Procedure or surgery | Videolarygoscope |
Primary outcome
Nasal trauma score
Time frame: 5 minutes from nasotracheal intubation
a score of 0 to 3 will be provided no bleeding, moderate bleeding, or severe bleeding
6 secondary outcomes
nasal intubation smoothness score
Time frame: During nasotracheal Intubation
Total intubation time
Time frame: During nasotracheal intubation
Laryngoscopy time
Time frame: During nasotracheal intubation
incidence of post operative sore throat
Time frame: Between 3 to 24 hours after intervention (nasotracheal intubation)
incidence of postoperative nasal discomfort
Time frame: Between 3 to 24 hours after intervention (nasotracheal intubation)
Incidence of post operative nasal bleeding or blood stained discharge
Time frame: Between 3 to 24 hours after intervention (nasotracheal intubation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 24891196Collins 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.
- Background: PubMed 36590192Bansal 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.
- Background: PubMed 20682569El-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.
- Background: PubMed 10960403Kim 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.
- Background: PubMed 16527796Morimoto 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.
- Background: PubMed 28921537Abrons 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.
- Individual participant dataSharing planned: No. no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cyprian Mendonca study director
University Hopsitals Coventry & Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasotracheal Intubation with Fibrescope and Nasotracheal Intubation with Video laryngoscope in people with No Disease, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Pairaudeau, FRCA (+44719121363, Charles.Pairaudeau2@uhcw.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal trauma score (time frame: 5 minutes from nasotracheal intubation). 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 NCT07353255, which also lists 6 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 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.