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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04959149
Other study ID # RNN/62/20/KE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date September 30, 2020

Study information

Verified date June 2022
Source Medical University of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 1. 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. 2. Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask. 3. 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. 4. After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given. 5. 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. 6. 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. 7. 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AirTraq videolaryngoscope
intubation of morbidly obese patient using Airtraq videolaryngoscope

Locations

Country Name City State
Poland Medical University of Lodz, Poland Lódz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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

Outcome

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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