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

Sponsor
Trakya University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03734965
Collaborator
(none)
100
1
2
38.5
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AWAKEN INTUBATION
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Aug 12, 2021
Anticipated Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: AWAKEN INTUBATION FIBEROPTIC

awaken intubation

Device: AWAKEN INTUBATION
Intubation

Experimental: AWAKEN INTUBATION VIDEOLARYNGOSCOPY

awaken intubation

Device: AWAKEN INTUBATION
Intubation

Outcome Measures

Primary Outcome Measures

  1. awaken intubation [It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal intubation]

    succesful intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trakya University Edirne Centrum Turkey 22030

Sponsors and Collaborators

  • Trakya University

Investigators

  • Principal Investigator: Sevtap Hekimoglu Sahin, Proffesor, Trakya University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Sag, Principal Investigator; Resident Doctor, Trakya University
ClinicalTrials.gov Identifier:
NCT03734965
Other Study ID Numbers:
  • TÜTF-BAEK 2018/90
First Posted:
Nov 8, 2018
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Sag, Principal Investigator; Resident Doctor, Trakya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021