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

The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Disorder
• Intervention / Treatment: Device: AWAKEN INTUBATION

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatih Sağ, resident; Phone Number: +90-284-235-76-41; Email: sag.fatih@gmail.com

Study Locations

• Turkey
  • Centrum
    • Edirne, Centrum, Turkey, 22030
      • Recruiting
      • Trakya University
      • Contact: Fatih Sağ, resident; Phone Number: +90-284-235-76-41; Email: sag.fatih@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AWAKEN INTUBATION FIBEROPTIC; awaken intubation	Device: AWAKEN INTUBATION; Intubation
EXPERIMENTAL: AWAKEN INTUBATION VIDEOLARYNGOSCOPY; awaken intubation	Device: AWAKEN INTUBATION; Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
awaken intubation	succesful intubation	It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal intubation

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 12, 2021
• Study Completion (ANTICIPATED): October 15, 2021

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (ACTUAL): November 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: fiberoptic; videolaryngoscopy; aweken intubation
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: TÜTF-BAEK 2018/90

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No