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Bariatric Surgery CandidateNCT03715257

Evaluation of Advanced Extubation Techniques in Bariatric Surgery

A study testing 14F staged extubation set guidewire and Tube changing catheter in people with Bariatric Surgery Candidate and Extubation, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Bariatric Surgery Candidate, Extubation
What is being tested?
14F staged extubation set guidewire and Tube changing catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 1 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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%

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kocaeli Derince Education and Research Hospital

    Derince, Kocaeli, 41400

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
14F staged extubation set guidewire, Tube changing catheter
Keywords
Advanced extubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 14F staged extubation set guidewireDevice

    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)

  • Tube changing catheterDevice

    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)

Study groups in NCT03715257
Study groupRoleWhat they receive
14F staged extubation set guidewireActive comparator14F 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)
Receives: Device: 14F staged extubation set guidewire
Tube changing catheterActive comparatorTube 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)
Receives: Device: Tube changing catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%)

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2018
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03715257
Sponsor's protocol ID
KIA 2018/19
Status last verified
Mar 2021
First submitted
27 Jul 2018
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 14F staged extubation set guidewire and Tube changing catheter in people with Bariatric Surgery Candidate and Extubation, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

obese patient's cook staged extubation set tolerance (guidewire and tube changing catheter) (time frame: Up to 20 minutes (after extubation at minute 0, 5,10,15,20)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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