Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation

NCT ID: NCT06386757

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-03-01

Brief 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, 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.

Conditions

Maxillofacial Injuries; Nasal Bleeding; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group Ι Combined Video Laryngoscopy (VL) and Bougie

Group Ι Combined Video Laryngoscopy (VL) and Bougie: Nasal intubation will be performed using a video laryngoscope and a bougie.

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Group ΙI Direct Laryngoscopy (DL) and Bougie :

Nasal intubation will be performed using a traditional direct laryngoscope and a bougie.

Group Type: ACTIVE_COMPARATOR

Combined Direct Laryngoscopy (DL) and Bougie

Intervention Type: PROCEDURE

To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation

Interventions

Combined Video Laryngoscopy (VL) and Bougie

To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation.

Intervention Type: PROCEDURE

Combined Direct Laryngoscopy (DL) and Bougie

To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who will undergo maxillofacial surgeries with nasotracheal intubation..
• ASA I/II patients.
• BMI <35

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University

OTHER

Sponsor Role: lead

Responsible Party

Soudy Salah Hammad

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Alazhary, MD

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Ayman M Eldemrdash, MD

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Aswan University

Aswān, Aswan Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Soudy S Hammad, MD

Role: CONTACT

soudi.salah@aswu.edu.eg

+201014761523

Mohammed E Yahia, MSc

Role: CONTACT

01125257916

Facility Contacts

Soudy S Hammad, MD

Role: primary

soudi.salah@aswu.edu.eg

+201014761523

Mohammed E Yahia, MSc

Role: backup

01125257916

Mohammed A Alazhary, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 34912623 (View on PubMed)

Kumar 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.

Reference Type: BACKGROUND

PMID: 32346248 (View on PubMed)

Prasant 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.

Reference Type: BACKGROUND

PMID: 25628477 (View on PubMed)

Eldemrdash 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.

Reference Type: DERIVED

PMID: 40642178 (View on PubMed)

Other Identifiers

Asw.U. 911/3/24

Identifier Type: -

Identifier Source: org_study_id