Maxillofacial InjuriesNCT06386757
Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation
A study testing Combined Video Laryngoscopy (VL) and Bougie and Combined Direct Laryngoscopy (DL) and Bougie in people with Maxillofacial Injuries and Nasal Bleeding, run by Aswan University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Maxillofacial Injuries, Nasal Bleeding, Intubation Complication
- What is being tested?
- Combined Video Laryngoscopy (VL) and Bougie and Combined Direct Laryngoscopy (DL) and Bougie
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Mar 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo maxillofacial surgeries with nasotracheal intubation..
- ASA I/II patients.
- BMI <35
Who cannot join
- Having bleeding diathesis and abnormal Prothrombin Time (PT), Partial Thromboplastin Time (PTT), or platelet counts.
- Local causes of bleeding as adenoid
- On medications that alter blood coagulation as anticoagulants and antiplatlets.
- Patients in which either intubation failed on both nostrils or where intubation was only possible with a tube smaller than 6.0 mm internal diameter(ID).
- Anticipated difficult airways.
- ASA III/IV.
Trial locations and contacts
1 site in 1 country.
Mohammed E Yahia, MSc contact
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, Aswan Governorate, 81528
Soudy S Hammad, MD, +201014761523, soudi.salah@aswu.edu.eg
Mohammed E Yahia, MSc, 01125257916
About this study
Official title: Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation in Maxillofacial Trauma Patients: a Randomized Controlled Trial
The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension
Read the detailed description
Maxillofacial fractures occur in a significant proportion worldwide and can occur as an isolated injury or in combination with other severe injuries including cranial, spinal, and upper and lower body injuries requiring prompt diagnosis with possible emergency interventions. The epidemiology of facial fractures varies with regard to injury type, severity, and cause and depends on the population studied.
Traumatic maxillofacial fractures are known to have difficulty in airway management due to anatomical and functional reasons. In many situations, treatment of facial fractures requires tracheal intubation. For fractures that involve occlusion, such as mandibular and Lefort fractures, oral intubation inhibits appropriate resolution of the occlusion. In these situations, nasotracheal intubation is indicated.
Direct laryngoscopic (DL) nasal intubations may be challenging if there is altered airway anatomy, difficulty in advancing the endotracheal tube through the glottis or in providers who are in training or those with less experience, even for patients with normal airway anatomy. The presence of cervical spine injury limit neck extension and makes airway manipulation more difficult. The use of Magill forceps is not always successful and is associated with endotracheal tube cuff damage and postoperative pharyngitis.
Video laryngoscopy (VL) is an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade, which provides an indirect view of the glottis and surrounding structures during intubation displayed on a monitor. Use of video laryngoscopes has been shown to result in higher first intubation success, better laryngoscopic views, less mucosal trauma.
A bougie that is a long, stiff plastic wand is required to direct the tube to the glottis through manipulation through nasal route. bougie overcame the limitations of endotracheal tube direction and provided an advantage of rail-roading the tube over the bougie under vision leaving no possibility of trauma caused by direct or magill forceps tube manipulation.
Epistaxis is the most common complication encountered during nasotracheal (NT) intubation and may have serious consequences, such as lifethreatening bleeding and airway obstruction by aspirated blood. In addition, it may occur even when mucosal vasoconstriction, a lubricated tracheal tube and careful manipulation of the tube during insertion are employed.
- Being tested
- Combined Video Laryngoscopy (VL) and Bougie, Combined Direct Laryngoscopy (DL) and Bougie
- Keywords
- nasal intubation, videolaryngscopy, direct laryngscopy, bogie stylet
- Medical subject headings
- Maxillofacial Injuries, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Video Laryngoscopy (VL) and BougieProcedure or surgery
To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation.
Combined Direct Laryngoscopy (DL) and BougieProcedure or surgery
To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation
| Study group | Role | What they receive |
|---|---|---|
| Group Ι Combined Video Laryngoscopy (VL) and Bougie | Active comparator | Group Ι Combined Video Laryngoscopy (VL) and Bougie: Nasal intubation will be performed using a video laryngoscope and a bougie. |
| Group ΙI Direct Laryngoscopy (DL) and Bougie : | Active comparator | Nasal intubation will be performed using a traditional direct laryngoscope and a bougie. Receives: Procedure: Combined Direct Laryngoscopy (DL) and Bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nasal and oropharyngeal bleeding
Incidence of nasal and oropharyngeal bleeding using Fromme's ordinal scale which is used for assessment of the surgical field quality( V Rajanigandha, et al. 2023),we will modify this scale to evaluate airway as follows :
0- No bleeding (virtually bloodless field)
- Minimal bleeding ( not a nuisance to vision , no suctioning required)
- Mild bleeding (a nuisance to vision but does not compromises laryngeal tube insertion, occasional suctioning required )
- Moderate bleeding (slightly compromises laryngeal tube insertion, frequent suctioning required)
- Severe bleeding (significantly compromises laryngeal tube insertion, frequent suctioning required)
- Massive bleeding (cannot insert laryngeal tube, constant suctioning required)
Measured: Through study completion, average 60 minutes at 5, 15, 30 minutes
Secondary outcomes (3)
Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff
Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff
Measured: Within minutes
Overall rate of first trial success.
Overall rate of first trial success.
Measured: Within minutes
The use of magill forceps
The use of magill forceps
Measured: Within minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- These prospective, randomized, controlled clinical trials will be conducted at Aswan University Hospital on 62 patients who are scheduled for maxillofacial surgeries requiring nasal intubation.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soudy Salah Hammad, Aswan University
- Investigators
- Mohammed A Alazhary, MD, Principal investigator, Aswan UniversityAyman M Eldemrdash, MD, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386757
- Sponsor's protocol ID
- Asw.U. 911/3/24
- Status last verified
- May 2024
- First submitted
- 4 Apr 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nedrud SM, Baasch DG, Cabral JD, McEwen DS, Dasika J. Combined Video Laryngoscope and Fiberoptic Nasal Intubation. Cureus. 2021 Nov 11;13(11):e19482. doi: 10.7759/cureus.19482. eCollection 2021 Nov.
PubMed 34912623Kumar P, Sharma J, Johar S, Singh V. Guiding Flexible-Tipped Bougie Under Videolaryngoscopy: An Alternative to Fiberoptic Nasotracheal Intubation in Maxillofacial Surgeries. J Maxillofac Oral Surg. 2020 Jun;19(2):324-326. doi: 10.1007/s12663-020-01327-w. Epub 2020 Jan 24.
PubMed 32346248Prasant MC, Kar S, Rastogi S, Hada P, Ali FM, Mudhol A. Comparative Study of Blood Loss, Quality of Surgical Field and Duration of Surgery in Maxillofacial Cases with and without Hypotensive Anesthesia. J Int Oral Health. 2014 Nov-Dec;6(6):18-21.
PubMed 25628477Eldemrdash AM, Alazhary MA, Zaher ZZ, Hemaida TS, Yahia ME, Hammad SS. Comparison of Nasal and Oropharyngeal Bleeding in Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation in Maxillofacial Trauma: A Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Jul 3;2025:7797828. doi: 10.1155/anrp/7797828. eCollection 2025.
PubMed 40642178
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation in Maxillofacial Trauma Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06386757
- Acronym / sponsor ID
- Asw.U. 911/3/24
- Keywords
- nasal intubation, videolaryngscopy, direct laryngscopy, bogie stylet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension
Detailed description
Maxillofacial fractures occur in a significant proportion worldwide and can occur as an isolated injury or in combination with other severe injuries including cranial, spinal, and upper and lower body injuries requiring prompt diagnosis with possible emergency interventions. The epidemiology of facial fractures varies with regard to injury type, severity, and cause and depends on the population studied.
Traumatic maxillofacial fractures are known to have difficulty in airway management due to anatomical and functional reasons. In many situations, treatment of facial fractures requires tracheal intubation. For fractures that involve occlusion, such as mandibular and Lefort fractures, oral intubation inhibits appropriate resolution of the occlusion. In these situations, nasotracheal intubation is indicated.
Direct laryngoscopic (DL) nasal intubations may be challenging if there is altered airway anatomy, difficulty in advancing the endotracheal tube through the glottis or in providers who are in training or those with less experience, even for patients with normal airway anatomy. The presence of cervical spine injury limit neck extension and makes airway manipulation more difficult. The use of Magill forceps is not always successful and is associated with endotracheal tube cuff damage and postoperative pharyngitis.
Video laryngoscopy (VL) is an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade, which provides an indirect view of the glottis and surrounding structures during intubation displayed on a monitor. Use of video laryngoscopes has been shown to result in higher first intubation success, better laryngoscopic views, less mucosal trauma.
A bougie that is a long, stiff plastic wand is required to direct the tube to the glottis through manipulation through nasal route. bougie overcame the limitations of endotracheal tube direction and provided an advantage of rail-roading the tube over the bougie under vision leaving no possibility of trauma caused by direct or magill forceps tube manipulation.
Epistaxis is the most common complication encountered during nasotracheal (NT) intubation and may have serious consequences, such as lifethreatening bleeding and airway obstruction by aspirated blood. In addition, it may occur even when mucosal vasoconstriction, a lubricated tracheal tube and careful manipulation of the tube during insertion are employed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- These prospective, randomized, controlled clinical trials will be conducted at Aswan University Hospital on 62 patients who are scheduled for maxillofacial surgeries requiring nasal intubation.
| Arm | Type | Receives |
|---|---|---|
| Group Ι Combined Video Laryngoscopy (VL) and Bougie | Active comparator | –Group Ι Combined Video Laryngoscopy (VL) and Bougie: Nasal intubation will be performed using a video laryngoscope and a bougie. |
| Group ΙI Direct Laryngoscopy (DL) and Bougie : | Active comparator | Procedure: Combined Direct Laryngoscopy (DL) and BougieNasal intubation will be performed using a traditional direct laryngoscope and a bougie. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will undergo maxillofacial surgeries with nasotracheal intubation..
- ASA I/II patients.
- BMI <35
Key exclusion criteria (6 listed)
- Having bleeding diathesis and abnormal Prothrombin Time (PT), Partial Thromboplastin Time (PTT), or platelet counts.
- Local causes of bleeding as adenoid
- On medications that alter blood coagulation as anticoagulants and antiplatlets.
- Patients in which either intubation failed on both nostrils or where intubation was only possible with a tube smaller than 6.0 mm internal diameter(ID).
- Anticipated difficult airways.
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 |
|---|---|---|
| Combined Video Laryngoscopy (VL) and BougieTo compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation. | Procedure or surgery | – |
| Combined Direct Laryngoscopy (DL) and BougieTo compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation | Procedure or surgery | Group ΙI Direct Laryngoscopy (DL) and Bougie : |
Primary outcome
Incidence of nasal and oropharyngeal bleeding
Time frame: Through study completion, average 60 minutes at 5, 15, 30 minutes
Incidence of nasal and oropharyngeal bleeding using Fromme's ordinal scale which is used for assessment of the surgical field quality( V Rajanigandha, et al. 2023),we will modify this scale to evaluate airway as follows : 0- No bleeding (virtually bloodless field) 1. Minimal bleeding ( not a nuisance to vision , no suctioning required) 2. Mild bleeding (a nuisance to vision but does not compromises laryngeal tube insertion, occasional suctioning required ) 3. Moderate bleeding (slightly compromises laryngeal tube insertion, frequent suctioning required) 4. Severe bleeding (significantly compromises laryngeal tube insertion, frequent suctioning required) 5. Massive bleeding (cannot insert laryngeal tube, constant suctioning required)
3 secondary outcomes
Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff
Time frame: Within minutes
Overall rate of first trial success.
Time frame: Within minutes
The use of magill forceps
Time frame: Within minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 34912623Nedrud SM, Baasch DG, Cabral JD, McEwen DS, Dasika J. Combined Video Laryngoscope and Fiberoptic Nasal Intubation. Cureus. 2021 Nov 11;13(11):e19482. doi: 10.7759/cureus.19482. eCollection 2021 Nov.
- Background: PubMed 32346248Kumar P, Sharma J, Johar S, Singh V. Guiding Flexible-Tipped Bougie Under Videolaryngoscopy: An Alternative to Fiberoptic Nasotracheal Intubation in Maxillofacial Surgeries. J Maxillofac Oral Surg. 2020 Jun;19(2):324-326. doi: 10.1007/s12663-020-01327-w. Epub 2020 Jan 24.
- Background: PubMed 25628477Prasant MC, Kar S, Rastogi S, Hada P, Ali FM, Mudhol A. Comparative Study of Blood Loss, Quality of Surgical Field and Duration of Surgery in Maxillofacial Cases with and without Hypotensive Anesthesia. J Int Oral Health. 2014 Nov-Dec;6(6):18-21.
- Derived from this study: PubMed 40642178Eldemrdash AM, Alazhary MA, Zaher ZZ, Hemaida TS, Yahia ME, Hammad SS. Comparison of Nasal and Oropharyngeal Bleeding in Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation in Maxillofacial Trauma: A Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Jul 3;2025:7797828. doi: 10.1155/anrp/7797828. eCollection 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohammed E Yahia, MSc contact
Mohammed A Alazhary, MD principal investigator
Aswan University
Ayman M Eldemrdash, MD principal investigator
Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Video Laryngoscopy (VL) and Bougie and Combined Direct Laryngoscopy (DL) and Bougie in people with Maxillofacial Injuries and Nasal Bleeding, run by Aswan University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2025. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soudy S Hammad, MD (+201014761523, soudi.salah@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nasal and oropharyngeal bleeding (time frame: Through study completion, average 60 minutes at 5, 15, 30 minutes). 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 NCT06386757, which also lists 4 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 21 Feb 2025.