Atomization Vs. Nebulization for Airway Topicalization During Awake Nasotracheal Fiberoptic Intubation

NCT05320731 | Completed

• 1 other identifier: ZU-IRB #9351
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Intubation of difficult airway is a challenge for anesthetist. There many causes of difficult airway, and previous studies concluded that awake fiber-optic intubation (AFOI) is the gold standard for the management of these patients. Several studies showed that airway nerve blocks provide rapid and deep airway anesthesia, however, due to their several disadvantages, topicalization of the airway represents a promising alternative to them. Some studies revealed that nebulization and atomization of the airway provide adequate anesthesia for AFOI. In the present study, we try to find out which is more effective for topicalization of the airway during nasotracheal AFOI; nebulization or atomization. We used a simple atomization device as a modification of the McKenzie technique.

Conditions

Awake Fiberoptic Intubation

Keywords

Awake fiberoptic intubation; Nebulization; Atomization

Outcome Measures

Primary Outcomes (1)

• Bronchoscopy-guided intubation time

  Time from passing the flexible fiberoptic bronchoscope tip through the nostril to the first reading obtained by the capnograph after endotracheal intubation

  Intraoperative (during intubation)

Secondary Outcomes (4)

• Intubating Condition Score:

  Intraoperative (during intubation)

• Vocal Cord Position Score:

  Intraoperative (during intubation)

• Intraoperative Patient Comfort Score:

  Intraoperative (during and immediately post-intubation)

• Postoperative Patient Satisfaction Score:

  Postoperative 24 hours

Study Arms (2)

Nebulization with lidocaine

ACTIVE COMPARATOR

A face mask nebulizer with oxygen flow rate of 8 L/min will be used to deliver 10 mL of 2% lidocaine. Patients will be encouraged to inhale deeply to facilitate entrainment of nebulized LA into their airway. Adequate topical anesthesia will be confirmed by heaviness or numbness of the tongue.

Procedure: Nebulization with lidocaine

Atomization with lidocaine

ACTIVE COMPARATOR

Our simple atomization device, a modification of the McKenzie technique, will be used. One end of oxygen bubble tubing will be cut to fit into the barrel of 1 mL syringe and attached to one connector of a 3-way tap. A 10-mL syringe filled with 2% lidocaine will be attached to the other connector of the 3-way tap. A 6 Fr suction catheter, with its colored end cut and its distal blind end cut open, will be attached to oxygen bubble tubing via the male Luer connector of the 3-way tap. The other end of bubble tubing will be then attached to an oxygen source turned on to deliver a flow of 6 L/min. As LA is slowly atomized as a jet-like spray, the catheter will be directed towards the soft palate and posterior pharynx in a controlled fashion during patients' inspiration to topicalize the airway. Patients will be asked to take full vital capacity breaths of atomized LA contained oxygen. Adequate topical anesthesia will be confirmed by tongue heaviness or numbness

Procedure: Atomization with lidocaine

Interventions

Nebulization with lidocaine PROCEDURE

A face mask nebulizer with oxygen flow rate of 8 L/min will be used to deliver 10 mL of 2% lidocaine. Patients will be encouraged to inhale deeply to facilitate entrainment of nebulized LA into their airway. Adequate topical anesthesia will be confirmed by heaviness or numbness of the tongue.

Nebulization with lidocaine

Atomization with lidocaine PROCEDURE

A simple atomization device as a modification of the McKenzie technique will be used. One end of oxygen bubble tubing will be cut to fit into the barrel of 1 mL syringe and attached to one connector of a 3-way tap. A 10-mL syringe filled with 2% lidocaine will be attached to the other connector of the 3-way tap. A 6 Fr suction catheter, with its colored end cut and its distal blind end cut open, will be attached to oxygen bubble tubing via the male Luer connector of the 3-way tap. The other end of bubble tubing will be then attached to an oxygen source turned on to deliver a flow of 6 L/min. As LA is slowly atomized as a jet-like spray, the catheter will be directed towards the soft palate and posterior pharynx in a controlled fashion during patients' inspiration to topicalize the airway. Patients will be asked to take full vital capacity breaths of atomized LA contained oxygen. Adequate topical anesthesia will be confirmed by tongue heaviness or numbness

Atomization with lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Consent obtained from all patients included in this study.
• Age 18 - 60 years, of both sexes.
• ASA class I, II and III.
• Anticipated difficult airway; SARI score ≥ 4, airway pathology, craniofacial abnormalities, or cervical spine instability.
• Scheduled for elective non-cardiac surgery requiring general anesthesia and endotracheal intubation.

You may not qualify if:

• Patient refusal, uncooperative and mentally retarded patients.
• Full stomach patients.
• Patients with nasal fractures or trauma, fracture base of the skull, bleeding disorder, epistaxis or active oral bleeding.
• Active cough or respiratory tract infection and bronchial asthma.
• Allergy to lidocaine.
• Raised intracranial pressure or intraocular pressure.
• Cerebral aneurysm, history of recent acute myocardial infarction or cerebrovascular accident.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (15)

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  PMID: 5674435 BACKGROUND

• Murphy P. A fibre-optic endoscope used for nasal intubation. Anaesthesia. 1967 Jul;22(3):489-91. doi: 10.1111/j.1365-2044.1967.tb02771.x. No abstract available.

  PMID: 4951601 BACKGROUND

• Gupta B, Kohli S, Farooque K, Jalwal G, Gupta D, Sinha S, Chandralekha. Topical airway anesthesia for awake fiberoptic intubation: Comparison between airway nerve blocks and nebulized lignocaine by ultrasonic nebulizer. Saudi J Anaesth. 2014 Nov;8(Suppl 1):S15-9. doi: 10.4103/1658-354X.144056.

  PMID: 25538514 BACKGROUND

• Dhasmana SC. Nasotracheal fiberoptic intubation: patient comfort, intubating conditions and hemodynamic stability during conscious sedation with different doses of dexmedetomidine. J Maxillofac Oral Surg. 2014 Mar;13(1):53-8. doi: 10.1007/s12663-012-0469-0. Epub 2013 Jan 18.

  PMID: 24644397 BACKGROUND

• Kundra P, Kutralam S, Ravishankar M. Local anaesthesia for awake fibreoptic nasotracheal intubation. Acta Anaesthesiol Scand. 2000 May;44(5):511-6. doi: 10.1034/j.1399-6576.2000.00503.x.

  PMID: 10786733 BACKGROUND

• Mathur PR, Jain N, Kumar A, Thada B, Mathur V, Garg D. Comparison between lignocaine nebulization and airway nerve block for awake fiberoptic bronchoscopy-guided nasotracheal intubation: a single-blind randomized prospective study. Korean J Anesthesiol. 2018 Apr;71(2):120-126. doi: 10.4097/kjae.2018.71.2.120. Epub 2018 Apr 2.

  PMID: 29619784 BACKGROUND

• Techanivate A, Leelanukrom R, Prapongsena P, Terachinda D. Effectiveness of mouthpiece nebulization and nasal swab stick packing for topical anesthesia in awake fiberoptic nasotracheal intubation. J Med Assoc Thai. 2007 Oct;90(10):2063-71.

  PMID: 18041425 BACKGROUND

• Mostafa SM, Murthy BV, Hodgson CA, Beese E. Nebulized 10% lignocaine for awake fibreoptic intubation. Anaesth Intensive Care. 1998 Apr;26(2):222-3. No abstract available.

  PMID: 9564411 BACKGROUND

• Ahmed I. Regional and Topical Anesthesia for Awake Endotracheal Intubation. In: Hadzic's Textbook of Regional Anesthesia and Acute Pain Management, 2nd ed: McGraw Hill Professional. 2017:20;289-99.

  BACKGROUND

• Sinha S, Chakraborty, Mondal A, et al. (2019). Comparative study of nebulisation, airway nerve block and atomisation with lignocaine in topical airway anaesthesia for awake fibre-optic intubation. Journal of Evidence Based Medicine and Healthcare. 6. 1882-1886. 10.18410/jebmh/2019/383.

  BACKGROUND

• Gjonaj ST, Lowenthal DB, Dozor AJ. Nebulized lidocaine administered to infants and children undergoing flexible bronchoscopy. Chest. 1997 Dec;112(6):1665-9. doi: 10.1378/chest.112.6.1665.

  PMID: 9404766 BACKGROUND

• British Thoracic Society Bronchoscopy Guidelines Committee, a Subcommittee of Standards of Care Committee of British Thoracic Society. British Thoracic Society guidelines on diagnostic flexible bronchoscopy. Thorax. 2001 Mar;56 Suppl 1(Suppl 1):i1-21. doi: 10.1136/thorax.56.suppl_1.i1. No abstract available.

  PMID: 11158709 BACKGROUND

• Reed AP. Preparation of the patient for awake flexible fiberoptic bronchoscopy. Chest. 1992 Jan;101(1):244-53. doi: 10.1378/chest.101.1.244. No abstract available.

  PMID: 1729077 BACKGROUND

• Chavan G, Chavan AU, Patel S, Anjankar V, Gaikwad P. Airway Blocks Vs LA Nebulization- An interventional trial for Awake Fiberoptic Bronchoscope assisted Nasotracheal Intubation in Oral Malignancies. Asian Pac J Cancer Prev. 2020 Dec 1;21(12):3613-3617. doi: 10.31557/APJCP.2020.21.12.3613.

  PMID: 33369459 BACKGROUND

• Yadav U, Kumar A, Gupta P. A Comparative Study of Airway Nerve Blocks and Atomized Lidocaine by the Laryngo-Tracheal Mucosal Atomization Device (LMA MADgic) Airway for Oral Awake Fiberoptic Intubation. Cureus. 2021 Jun 20;13(6):e15772. doi: 10.7759/cureus.15772. eCollection 2021 Jun.

  PMID: 34295582 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ashraf A Torki, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  PRINCIPAL INVESTIGATOR

• Mona A Shahin, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both the anesthesiologist performing the fibroscopy and the data collector will be blind to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Zagazig University (Principal Investigator)

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: February 20, 2022
• Primary Completion: July 20, 2024
• Study Completion: August 15, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)