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

NCT06386757 | Recruiting

• 1 other identifier: Asw.U. 911/3/24
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Maxillofacial Injuries; Nasal Bleeding; Intubation Complication

Keywords

nasal intubation; videolaryngscopy; direct laryngscopy; bogie stylet

Outcome Measures

Primary Outcomes (1)

• 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) 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)

  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

  Within minutes

• Overall rate of first trial success.

  Within minutes

• The use of magill forceps

  Within minutes

Study Arms (2)

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.

Procedure: Combined Direct Laryngoscopy (DL) and Bougie

Interventions

Combined Video Laryngoscopy (VL) and Bougie PROCEDURE

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

Combined Direct Laryngoscopy (DL) and Bougie PROCEDURE

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

Group ΙI Direct Laryngoscopy (DL) and Bougie :

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, Aswan Governorate, 81528, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 34912623 BACKGROUND

• 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.

  PMID: 32346248 BACKGROUND

• 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.

  PMID: 25628477 BACKGROUND

• 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.

  PMID: 40642178 DERIVED

MeSH Terms

Conditions

Maxillofacial Injuries; Epistaxis

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Mohammed A Alazhary, MD

  Aswan University

  PRINCIPAL INVESTIGATOR

• Ayman M Eldemrdash, MD

  Aswan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soudy S Hammad, MD

CONTACT

+201014761523; soudi.salah@aswu.edu.eg

Mohammed E Yahia, MSc

CONTACT

01125257916

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 26, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)