Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04872881 |
| Other study ID # |
eliftez |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Bozyaka Training and Research Hospital |
| Contact |
Elif Göktas |
| Phone |
05062073485 |
| Email |
e.goktas44[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Tracheostomy is a vital procedure in the ICU to maintain the airway and prevent complications
that may occur due to intubation. It helps reduce the dead space volume, airway resistance
and provides comfort to the patients during the weaning from mechanical ventilation. Two
methods are widely used in Percutaneous Dilatational Tracheostomy (PDT): The multiple
dilation method (Ciaglia) and the Griggs method.Griggs method will be used in the study.
The Griggs Method: A 10-15 millimeter skin incision is made between the level of the
second-third tracheal rings. The location of the needle is confirmed by entering the trachea
with an injector filled with 2-3 mL saline from the midline and aspirating air. A J-tipped
guidewire is advanced through the needle and the needle is removed. A special forceps with a
channel at the tip, through which the guidewire can pass is used in this method. The forceps
advanced through the guidewire and then subcutaneous tissues and trachea are dilated in one
or two steps. When the stoma is large enough to insert the cannula, it is placed in the
trachea and fixed.
Patients who will undergo tracheostomy in the ICU will be included in the study and randomly
assigned into two groups. Two different methods, endotracheal tube (ET) or laryngeal mask
(LMA), will be used during the tracheostomy for airway management. In both methods,
fiberoptic bronchoscopy will assist the procedure.
Researchers aim to compare the two airway management methods in terms of complications,
procedure time, and the number of staff needed.
Description:
Protection of the airway during percutaneous tracheostomy can be achieved with an
endotracheal tube (ETT) or laryngeal mask (LMA).Researchers aimed to compare the use of ETT
and LMA in this prospective, randomized study.
Multiple blood gas analyses will be performed during the procedure. Airway failure rates,
total procedure time, the occurrence of gastric distension and regurgitation, number of staff
needed, complications (Hypercarbia, hypoxia, etc.), and hemodynamic parameters (Non-invasive
blood pressure, pulse oximeter, electrocardiogram) will be compared.
Patients will be divided into two groups with simple randomization. A-priori study with 14
patients suggested 52 patients are needed for statistical significance (G*Power 3.1 software
was used). Patients will be reviewed for suitability for procedure as stated in the inclusion
criteria. Patients and/or relatives will be informed about the study and informed consent
will be obtained. Invasive arterial blood pressure monitoring of the patients will be
available. Before the procedure, the patients' fasting period for 6 hours will be completed
and the nasogastric catheter will be removed. Arterial blood gas sample will be checked
before the procedure begins. By placing a transverse elevation under the shoulders, the
patients' neck will be extended as appropriate. Patients will be positioned after induction
with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 mcg/kg fentanyl IV, and positioning time
will be recorded. Propofol infusion at the dose of 6 mg/kg/hour will be started.
Electrocautery will be available. Patients will be mechanically ventilated with a controlled
mode (CMV) with 7ml/kg tidal volume, 15/min frequency, and 5 cmH2O PEEP. Preoxygenation will
be made with 100% FiO2 for 5 minutes.
ETT Group: ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just
above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with
successful ventilation after repositioning. If the ETT can not be repositioned within 5
minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with
the usual method (ETT cuff will be inflated under the vocal cords).
LMA Group: After selecting the appropriate LMA size for the patient, the ET Tube will be
removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff
deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA
cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy
will be continued with the usual method (ETT cuff will be inflated under the vocal cords).
After the ventilation is provided, arterial blood gas samples will be analyzed at the 3rd,
6th, and 10th minutes and every 5 minutes afterward until the end of the procedure. In both
groups, fiberoptic bronchoscopy will assist the procedure and "Duration of the Confirmation
of the Incision Site" will be noted. The bronchoscopy period will start when the physician
who will perform the bronchoscope takes the bronchoscope in his hand and ends with the
confirmation of the incision site. The area will be cleaned with iodide skin antiseptic,
covered with a sterile cover, and surgical tools and tracheostomy kit will be prepared for
the procedure. This will be recorded as "Preparation Time". Tracheostomy will preferably be
performed between the 2nd and 3rd cartilage rings but one upper or lower level will be used
if needed (per patients' anatomy). Local anesthesia will be applied for the incision site
with 4 ml of local anesthetic solution containing %2 lidocaine and %0,00125 epinephrine.
"Procedure Time" will start with skin incision and end with successful ventilation after the
tracheostomy cannula cuff is inflated.
Gastric distension, hypoxia, regurgitation, hemodynamic parameters (every 3 minutes),
complications, and the number of staff will be recorded. When the tracheostomy cannula is
placed and the patient is ventilated, the procedure will be terminated and confirmed with an
anteroposterior chest x-ray.
SPSS (Statistical Package for Social Sciences version 24) was used for statistical
calculation. Parametric test results were reported as mean and standard deviation and
non-parametric test results as number and percentage or median and interquartile range. The
compliance of the data to normal distribution was determined by the single sample
Kolmogorov-Smirnov test. Normally distributed quantitative data were compared with the
independent sample T-Test, quantitative data that did not follow normal distribution were
compared with the Mann-Whitney U test. A Chi-square test was used to compare qualitative
data.
The significance level was determined as p <0.05 at the 95% confidence interval for the
analyzes.
