Evaluation of Advanced Extubation Techniques in Bariatric Surgery

Evaluation of Advanced Extubation Techniques in Bariatric Surgery: A Randomized Controlled Prospective Study

The aim of prospective clinic study is to compare the tolerance and effectivity of Cook tube changing catheter and staged extubation set following laparoscopic morbid obesity surgery. The use of step extubation in difficult extubation is life-saving. The use of cascade extubation set in morbid obese and especially bariatric surgery patients is also life-saving.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Extubation
• Intervention / Treatment: Device: 14F staged extubation set guidewire; Device: Tube changing catheter

Detailed Description

Extubation in difficult airway can be defined as transition from a controlled environment to an uncontrolled. According to the results of the NAP4 study conducted in England, one third of the anaesthesia related major airway complications occur during awakening or compilation and the mortality rate was 5%. The Difficult Airway Society extubation guideline published in 2015 suggested awake extubation in patients with risk for airway or systemic risk factors, and mentioned about the importance of the benefit from further techniques such as Bailey maneuver, remifentanyl technique and tube changing catheters. The aim of prospective clinic study is to compare the tolerance and effectivity of Cook tube changing catheter and staged extubation set following laparoscopic morbid obesity surgery.

The Cook staged extubation set (Cook Medical) has been developed to facilitate management of the difficult airway. A guidewire inserted before tracheal extubation provides access to the subglottic airway should re-intubation be required. This prospective study examines patients' tolerance of the guidewire and its impact on clinical status around tracheal extubation in the postoperative unit.Vital signs, incidence of symptoms and patient tolerance of the wire are recorded.

MATERIAL AND METHOD

Researches conduct a prospective study using the Cook staged extubation set in 100 patients undergoing tracheal extubation in the operation room of Derince hospital.

Local ethics committee approval and written informed consent are planned to work with 100 patients.The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)and the other with tube changing catheter (n=50). Cuff leakage test is done prior to extubation and 3 mg/kg intravenous sugammadex is administered. The patients who reached the awake extubation criteria are extubated using one of the above catheters. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter.

During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.

Induction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation (such as FastTrack, videolaryngoscopy or fiberoptic intubation), perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.Patients receive intravenous lidocaine at a dose of 1 mg / kg before induction and extubation. Prednisolone 1 mg / kg intravenous is given when necessary, such as laryngospasm development or recurrent airway manipulations. Duration of operation, surgical method (laparotomy / laparoscopy), agents used in induction and postoperative analgesia, use of blood, blood product and vasopressor are recorded. Before extubation, the cuff leakage test is performed and the extubations are made at a height of 30-35º degree. In the induction and maintenance of anesthesia, patients are given propofol 2 mg / kg, rocuronium 0.6 mg / kg, fentanyl 1mcg / kg and sevoflurane 2%. For extubation sugammadex is given iv at a dose of 3 mg / kg.

In patients who were extubation with cook staged extubation set; coughing, straining, hemodynamic parameter change, 20% heart rate and / or changes in arterial blood pressure and presence of hypoxemia (SpO2 <94%) are recorded.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli
    • Derince, Kocaeli, Turkey, 41400
      • Kocaeli Derince Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 18 years
• Patients who have undergone obesity surgery
• ASA 2-3 patients
• Patients who have received written informed consent

Exclusion Criteria:

• Patients under the age of 18
• Patients refusing to participate in the study
• Patients under emergency conditions
• Earlier laryngeal and tracheal surgery, those who undergo lung surgery
• Those with allergies to lidocaine
• Patients with FEV1 / FVC below 60%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 14F staged extubation set guidewire; 14F staged extubation set guidewire is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter. The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)	Device: 14F staged extubation set guidewire; 14F staged extubation set guidewire is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter. The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)
ACTIVE_COMPARATOR: Tube changing catheter; Tube changing catheter is an alternative extubation device. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter. The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)	Device: Tube changing catheter; Tube changing catheter Tube changing catheter is an alternative extubation device. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter. The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obese patient's cook staged extubation set tolerance (guidewire and tube changing catheter)	In patients who were extubation with cook staged extubation set; coughing, straining, hemodynamic parameter change, 20% heart rate and / or changes in arterial blood pressure and presence of hypoxemia (SpO2 <94%)	Up to 20 minutes (after extubation at minute 0, 5,10,15,20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful tracheal extubation and 14F staged extubation set guidewire patient tolerance	Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are records for the first 20 postoperative minutes.	Up to 20 minutes (after extubation at minute 0, 5,10,15,20)
Successful tracheal extubation and tube changing catheter patient tolerance	Tolerance of the patient to the catheter coughing, straining reflex. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are records for the first 20 postoperative minutes.	Up to 20 minutes (after extubation at minute 0, 5,10,15,20)

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital
• Investigators: Study Director: Emine Yurt, Anesthesiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Advanced extubation
• Other Study ID Numbers: KIA 2018/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No