The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal Intubation in Cervical Surgery

Not Applicable

• Conditions: Cervical Disorder
• Interventions: Device: AWAKEN INTUBATION

• Registration Number: NCT03734965
• Lead Sponsor: Trakya University

Brief Summary

Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.

Detailed Description

INTRODUCTION: Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.

METHODS: Patients in the ASA I-II-III risk group, aged 18-80 years, who will undergo cervical surgery operation between 01.04.2018 and 01.04.2020 by the Brain and Neurosurgeon at Trakya University Medical Faculty Hospital will be included. Patients will be prospectively randomized into 2 groups; Group F (intubation with fiberoptic in awake patients), Group V (intubation with videolaringoscopy in awake patients). In successful intubations the time between the time of access to the criterion laryngoscope and the appearance of the vocal cord will be assumed to be 60 seconds. Complications during intubation (mucosal injury, tooth trauma, lip injury, hypoxia (SpO2 \<95%) and esophageal intubation) will be recorded. After intubation, the presence of blood in the Endotracheal Tube (ETT) or sore throat, which is expressed by the patient after recovery, will also be recorded.

STATISTICAL METHODS: Student-T test or Mann Whitney U test will be applied among the groups. Ki-Kara test will be used to compare categorical data.

CONCLUSION: Evaluation of mortality and morbidity of the patients awake intubation with fiberoptic bronchoscopy and videolaryngoscopy for cervical trauma surgery.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Primary Completion: 2021-08-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Study Completion: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18-80 years who planning cervical surgery

Exclusion Criteria

• Patients with motor and sensory loss,
• Congenital neurological deficits, those with fiberoptic intubation inconveniences (with cerebrovascular case and hypertension),
• Patients with awake intubation (neuropsychiatric patients with orientation and cooperativeness impairment),
• Cardiovascular patients with local anesthetic allergy,
• Patients with difficult intubation history,
• Cervical surgery,
• Body mass index> 30 kg / m2,
• Mallampati score III-IV,
• Thyromental distance> 6 cm,
• Risk of gastric aspiration and pregnancies will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AWAKEN INTUBATION FIBEROPTIC	AWAKEN INTUBATION	awaken intubation
AWAKEN INTUBATION VIDEOLARYNGOSCOPY	AWAKEN INTUBATION	awaken intubation

Primary Outcome Measures

Name	Time	Method
awaken intubation	It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal intubation	succesful intubation

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Centrum, Turkey