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Face-to-face Intubation in Morbidly Obese

Primary Purpose

Intubation;Difficult, Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
AirTraq videolaryngoscope
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intubation;Difficult focused on measuring obesity, intubation, videolaryngoscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. BMI > 40 kg.m-2
  2. Patients qualified for planned sleeve gastrectomy.
  3. Patients of I and II class of ASA scale.
  4. Patients without history of difficult intubation.

Exclusion Criteria:

  1. Patients in life threatening states.
  2. Patients of III, IV, V and VI class of ASA scale.
  3. History of difficult intubation.

Sites / Locations

  • Medical University of Lodz, Poland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

face-to-face intubation

standard position intubation

Arm Description

intubation approach from front of the patient

intubation approach from behind the head of the patient

Outcomes

Primary Outcome Measures

time of intubation
time of intubation measured from grabbing the device to confirming the correct placement using EtCO2

Secondary Outcome Measures

effectiveness
effectiveness as number of correct placement of endotracheal tube in the trachea of the patient

Full Information

First Posted
December 28, 2020
Last Updated
June 9, 2022
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT04959149
Brief Title
Face-to-face Intubation in Morbidly Obese
Official Title
A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients. This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.
Detailed Description
Aim : The aim of the study is to evaluate the effectiveness and safety of face-to-face intubation in airway management. Methods : Patients admitted to hospital for elective sleeve gastrectomy procedure will be included in the study protocol. Before induction of anaesthesia the draw of the method will be held. The choice of method of intubation (inverse or typical) will be random. All patients will be positioned with the elevation of the upper body about 30 degrees. The standard anesthesia monitoring involves electrocardiogram, pulsoxymetry, non-invasive blood pressure and end-tidal carbon dioxide. Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask. The induction of general anesthesia will be performed by the intravenous administration of 1-2 µg.kg-1 of fentanyl and 2-2,5 mg.kg-1 propofol. After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given. After obtaining an optimal muscle relaxation (90 s.) patient will be intubated. In face-to-face method an anesthetist is standing in front of a patient. In typical intubation an anesthetist is standing behind the patient's head. In case of prolonged face-to-face intubation (>120 s) or 2 unsuccessful attempts, patients are supposed to be intubated in a traditional way with the same video laryngoscope. General anesthesia will be continued with desflurane and a mixture of the oxygen and air, volume-controlled ventilation parameters will be adjusted to age and ideal body weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation;Difficult, Obesity, Morbid
Keywords
obesity, intubation, videolaryngoscope

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
face-to-face intubation
Arm Type
Experimental
Arm Description
intubation approach from front of the patient
Arm Title
standard position intubation
Arm Type
Active Comparator
Arm Description
intubation approach from behind the head of the patient
Intervention Type
Device
Intervention Name(s)
AirTraq videolaryngoscope
Intervention Description
intubation of morbidly obese patient using Airtraq videolaryngoscope
Primary Outcome Measure Information:
Title
time of intubation
Description
time of intubation measured from grabbing the device to confirming the correct placement using EtCO2
Time Frame
during the intervention/procedure
Secondary Outcome Measure Information:
Title
effectiveness
Description
effectiveness as number of correct placement of endotracheal tube in the trachea of the patient
Time Frame
during the intervention/procedure
Other Pre-specified Outcome Measures:
Title
complications
Description
complications defined as soft tissue injuries ex lips or mucosa of oral cavity injury, sore throat after extubation, desaturations below 92%
Time Frame
immediately after the intervention/procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 40 kg.m-2 Patients qualified for planned sleeve gastrectomy. Patients of I and II class of ASA scale. Patients without history of difficult intubation. Exclusion Criteria: Patients in life threatening states. Patients of III, IV, V and VI class of ASA scale. History of difficult intubation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Gaszynski
Organizational Affiliation
Medical University of Lodz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Lodz, Poland
City
Łódź
ZIP/Postal Code
90-153
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
on request
Citations:
PubMed Identifier
26219732
Citation
Arslan ZI, Alparslan V, Ozdal P, Toker K, Solak M. Face-to-face tracheal intubation in adult patients: a comparison of the Airtraq, Glidescope and Fastrach devices. J Anesth. 2015 Dec;29(6):893-8. doi: 10.1007/s00540-015-2052-6. Epub 2015 Jul 29.
Results Reference
background
PubMed Identifier
30031381
Citation
Jeong H, Chae M, Seo H, Yi JW, Kang JM, Lee BJ. Face-to-face intubation using a lightwand in a patient with severe thoracolumbar kyphosis: a case report. BMC Anesthesiol. 2018 Jul 21;18(1):92. doi: 10.1186/s12871-018-0556-y.
Results Reference
background

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Face-to-face Intubation in Morbidly Obese

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