Obesity, Morbid Clinical Trial
Official title:
A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail
Verified date | June 2022 |
Source | Medical University of Lodz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Lodz, Poland | Lódz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lodz |
Poland,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | complications | complications defined as soft tissue injuries ex lips or mucosa of oral cavity injury, sore throat after extubation, desaturations below 92% | immediately after the intervention/procedure | |
Primary | time of intubation | time of intubation measured from grabbing the device to confirming the correct placement using EtCO2 | during the intervention/procedure | |
Secondary | effectiveness | effectiveness as number of correct placement of endotracheal tube in the trachea of the patient | during the intervention/procedure |
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