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).
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
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.
- Conditions
- Bariatric Surgery Candidate, Extubation
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Tube changing catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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.
- First posted23 Oct 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE YURT, Kocaeli Derince Education and Research Hospital
- Investigators
- Emine Yurt, Study director, Anesthesiology
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Extubation Techniques in Bariatric Surgery: A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT03715257
- Acronym / sponsor ID
- KIA 2018/19
- Conditions
- Bariatric Surgery Candidate, Extubation
- Keywords
- Advanced extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14F staged extubation set guidewire | Active comparator | Device: 14F staged extubation set guidewire14F 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 catheter | Active comparator | Device: Tube changing catheterTube 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years
- Patients who have undergone obesity surgery
- ASA 2-3 patients
- Patients who have received written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14F staged extubation set guidewire14F 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 catheterTube 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 |
Primary outcome
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)
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%)
2 secondary outcomes
Successful tracheal extubation and 14F staged extubation set guidewire patient tolerance
Time frame: Up to 20 minutes (after extubation at minute 0, 5,10,15,20)
Successful tracheal extubation and tube changing catheter patient tolerance
Time frame: Up to 20 minutes (after extubation at minute 0, 5,10,15,20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Yurt study director
Anesthesiology
1 site in 1 country: see every site and its status.
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.