MedDataX Logo

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

NCT ID: NCT03734965

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AWAKEN INTUBATION FIBEROPTIC

awaken intubation

Group Type ACTIVE_COMPARATOR

AWAKEN INTUBATION

Intervention Type DEVICE

Intubation

AWAKEN INTUBATION VIDEOLARYNGOSCOPY

awaken intubation

Group Type EXPERIMENTAL

AWAKEN INTUBATION

Intervention Type DEVICE

Intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AWAKEN INTUBATION

Intubation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trakya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatih Sag

Principal Investigator; Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sevtap Hekimoglu Sahin, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trakya University

Edirne, Centrum, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fatih Sağ, resident

Role: CONTACT

[email protected]
+90-284-235-76-41

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fatih Sağ, resident

Role: primary

[email protected]
+90-284-235-76-41

Sevtap Hekimoğlu Şahin, Professor

Role: backup

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TÜTF-BAEK 2018/90

Identifier Type: -

Identifier Source: org_study_id