Comparison of Endotracheal Intubation Using Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope (FIVE) in Obese Patients Undergoing Elective Surgeries Under General Anesthesia: A Randomized Controlled Trial

NCT03423563 | Completed DMC

• 1 other identifier: N-68-2016/Ms
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This disastrous outcome happens when the airway cannot be secured by intubation and face mask ventilation becomes difficult. Careful preoperative evaluation to identify patients in whom tracheal intubation and mask ventilation may prove to be difficult can save lives. Over the past 40 years, different techniques of tracheal intubation have been introduced, the most effective under different conditions being fiberoptic intubation. The flexible intubation video endoscope is a relatively new device which delivers clear, pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a full-format direct video imaging with improved image quality with a resolution higher than fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be broken or have transmission loss when wrapped around curves of only a few centimeters radius. After ethics approval and informed consent from patients, 60 obese patients aging from 20-60 years will randomly allocated and divided into two groups each is (Thirty) patients in each group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic bronchoscopy in (group 2). The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR) changes, success rate, number of attempts and complications in both groups. investigators expect from this study that flexible intubation video endoscope(FIVE) has become a good alternative and associated with better visualization of laryngeal structures in shorter time as compared to traditional flexible fiberoptic bronchoscopy.

Conditions

Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients

Outcome Measures

Primary Outcomes (1)

• Successful intubation

  Time in Minutes of successful intubation.

  Intraoperative

Secondary Outcomes (2)

• Rate of first successful intubation

  Intraoperative

• Second trial for successful intubation

  Intraoperative

Study Arms (2)

Flexible fiberoptic bronchoscopy

EXPERIMENTAL

Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios

Device: Flexible fiberoptic bronchoscopy

Fexible intubation video endoscopy

EXPERIMENTAL

Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor

Device: Fexible intubation video endoscopy

Interventions

Flexible fiberoptic bronchoscopy DEVICE

Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients

Flexible fiberoptic bronchoscopy

Fexible intubation video endoscopy DEVICE

Fexible intubation video endoscopy

Fexible intubation video endoscopy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 50 years.
• Scheduled for elective surgery requiring endotracheal intubation.
• Patient with ASA physical status I-II.

You may not qualify if:

• Unable to give consent
• Patient with ASA physical status more than II.
• Age \< 20years old and \>50years
• Pregnant patient.
• Known, difficult airway
• Loose teeth
• Require a rapid sequence induction,
• If special endotracheal tube (ETT) is needed for the case.
• Emergency surgeries

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Mai Wedad Ahmed: collaborator
• Norhan Abdelaleem Ali: collaborator
• Magdy Abdelmohsen Elsayed: collaborator
• Atef Kamel Salama: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Model Details: In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: February 6, 2018
• Study Start: January 4, 2018
• Primary Completion: February 5, 2018
• Study Completion: February 11, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)