Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03715257 |
| Other study ID # |
KIA 2018/19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
March 1, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Kocaeli Derince Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. The use of cascade
extubation set in morbid obese and especially bariatric surgery patients is also life-saving.
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.
