Evaluation of Advanced Extubation Techniques in Bariatric Surgery

NCT03715257 | Completed

• 1 other identifier: KIA 2018/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate; Extubation

Keywords

Advanced extubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Successful tracheal extubation and 14F staged extubation set guidewire patient tolerance

  Up to 20 minutes (after extubation at minute 0, 5,10,15,20)

• Successful tracheal extubation and tube changing catheter patient tolerance

  Up to 20 minutes (after extubation at minute 0, 5,10,15,20)

Study Arms (2)

14F staged extubation set guidewire

ACTIVE COMPARATOR

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

Tube changing catheter

ACTIVE COMPARATOR

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

Interventions

14F staged extubation set guidewire DEVICE

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)

14F staged extubation set guidewire

Tube changing catheter DEVICE

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)

Tube changing catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (1)

Kocaeli Derince Education and Research Hospital

Derince, Kocaeli, 41400, Turkey (Türkiye)

Location

Study Officials

• Emine Yurt

  Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical researcher

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: October 23, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)