Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

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ClinicalTrials.gov Identifier: NCT04872881

Recruitment Status : Not yet recruiting

First Posted : May 5, 2021

Last Update Posted : May 5, 2021

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Sponsor:

Information provided by (Responsible Party):

Elif Göktaş, Bozyaka Training and Research Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intubation, Intratracheal Tracheostomy Laryngeal Masks Intensive Care Units	Procedure: Endotracheal Tube Insertion Procedure: Laryngeal Mask Insertion Procedure: Fiberoptic Bronchoscopy Procedure: Radial Artery Monitoring Diagnostic Test: Anteroposterior chest x-ray Diagnostic Test: Arterial Blood Gas Analyses Drug: Propofol Fresenius Drug: Rocuronium Drug: Fentanyl	Phase 4

Show detailed description

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	52 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	There are two groups: ETT Group and LMA Group
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparison of Effectiveness of Different Airway Management Methods During Fiberoptic Bronchoscopy Assisted Percutaneous Tracheostomy
Estimated Study Start Date :	May 1, 2021
Estimated Primary Completion Date :	August 1, 2021
Estimated Study Completion Date :	October 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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)	Procedure: Endotracheal Tube Insertion ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords) Procedure: Fiberoptic Bronchoscopy After the patients' airway is established, the trachea and the process area will be displayed by the physician. The success rate will be increased by performing the procedure with fiberoptic bronchoscopy. Procedure: Radial Artery Monitoring The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way. Diagnostic Test: Anteroposterior chest x-ray When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray. Diagnostic Test: Arterial Blood Gas Analyses Hypoxia, acidosis and carbon dioxide increase will be followed Drug: Propofol Fresenius 2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started. Drug: Rocuronium 0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given. Other Name: Muscuron Drug: Fentanyl 1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.
Active Comparator: 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)	Procedure: Laryngeal Mask Insertion After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. Procedure: Fiberoptic Bronchoscopy After the patients' airway is established, the trachea and the process area will be displayed by the physician. The success rate will be increased by performing the procedure with fiberoptic bronchoscopy. Procedure: Radial Artery Monitoring The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way. Diagnostic Test: Anteroposterior chest x-ray When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray. Diagnostic Test: Arterial Blood Gas Analyses Hypoxia, acidosis and carbon dioxide increase will be followed Drug: Propofol Fresenius 2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started. Drug: Rocuronium 0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given. Other Name: Muscuron Drug: Fentanyl 1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.

Arm

Intervention/treatment

Active Comparator: 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)

Procedure: Endotracheal Tube Insertion

ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords)

Procedure: Fiberoptic Bronchoscopy

After the patients' airway is established, the trachea and the process area will be displayed by the physician.

The success rate will be increased by performing the procedure with fiberoptic bronchoscopy.

Procedure: Radial Artery Monitoring

The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way.

Diagnostic Test: Anteroposterior chest x-ray

When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray.

Diagnostic Test: Arterial Blood Gas Analyses

Hypoxia, acidosis and carbon dioxide increase will be followed

Drug: Propofol Fresenius

2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started.

Drug: Rocuronium

0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given.

Other Name: Muscuron

Drug: Fentanyl

1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.

Active Comparator: 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)

Procedure: Laryngeal Mask Insertion

After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted.

Procedure: Fiberoptic Bronchoscopy

After the patients' airway is established, the trachea and the process area will be displayed by the physician.

The success rate will be increased by performing the procedure with fiberoptic bronchoscopy.

Procedure: Radial Artery Monitoring

The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way.

Diagnostic Test: Anteroposterior chest x-ray

When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray.

Diagnostic Test: Arterial Blood Gas Analyses

Hypoxia, acidosis and carbon dioxide increase will be followed

Drug: Propofol Fresenius

2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started.

Drug: Rocuronium

0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given.

Other Name: Muscuron

Drug: Fentanyl

1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.

Outcome Measures

Primary Outcome Measures :

Arterial Blood Gas Analysis [ Time Frame: Before the procedure ]
Monitoring of hypoxia, acidosis, and carbon dioxide
Arterial Blood Gas Analysis [ Time Frame: 3rd minute after ventilation ]
Monitoring of hypoxia, acidosis, and carbon dioxide
Arterial Blood Gas Analysis [ Time Frame: 6th minute after ventilation ]
Monitoring of hypoxia, acidosis, and carbon dioxide
Arterial Blood Gas Analysis [ Time Frame: 10th minute after ventilation ]
Monitoring of hypoxia, acidosis, and carbon dioxide
Arterial Blood Gas Analysis [ Time Frame: When the tracheostomy cannula cuff is inflated ]
Monitoring of hypoxia, acidosis, and carbon dioxide
Positioning time [ Time Frame: Before the procedure ]
By placing a transverse elevation under the shoulders, the patients' neck will be extended as approprite.
The Reposition Time [ Time Frame: Before the procedure ]
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".
The LMA Insertion Time [ Time Frame: Before the procedure ]
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"
Duration of the Confirmation of the Incision Site [ Time Frame: Before the procedure ]
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
Preparation Time [ Time Frame: Before the procedure ]
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
Procedure Time [ Time Frame: 15 minutes after the procedure begins ]
"Procedure Time" will start with skin incision and end with successful ventilation after tracheostomy cannula cuff is inflated.

Secondary Outcome Measures :

Incidence of gastric distension [ Time Frame: Throughout the tracheostomy procedure ]
Incidence of hypoxia [ Time Frame: Throughout the tracheostomy procedure ]
Incidence of regurgitation [ Time Frame: Throughout the tracheostomy procedure ]
The number of staff needed [ Time Frame: Throughout the tracheostomy procedure ]
Heart rate [ Time Frame: Every 3 minutes during the procedure ]
Blood pressure [ Time Frame: Every 3 minutes during the procedure ]
Pulse oximeter [ Time Frame: Every 3 minutes during the procedure ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-pregnant patients over 18 years of age
Patients who need a tracheostomy
Patients whose opening method of tracheostomy is suitable for percutaneous tracheostomy.

Exclusion Criteria:

Refusal of the procedure by the patient or her legal representative
Patients under the age of 18
Body mass index> 35 patient group
Patients with a mass in the neck region for any reason
Skin infection at the procedure site
Coagulopathy
Inability to palpate the cricoid cartilage

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872881

Contacts

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Contact: Elif Göktaş	05062073485	e.goktas44@hotmail.com
Contact: Zeki T TEKGUL	05073341373	zekittekgul@yahoo.com

Sponsors and Collaborators

Bozyaka Training and Research Hospital

Investigators

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Study Chair:	Elif Göktaş	Izmir Bozyaka Research and Trainings Hospital
Study Chair:	Zeki T TEKGUL	Izmir Bozyaka Research and Trainings Hospital
Study Chair:	Hüseyin ÖZKARAKAŞ	Izmir Bozyaka Research and Trainings Hospital

More Information

Additional Information:

A prospective randomised controlled trial of the LMA Supreme vs cuffed tracheal tube as the airway device during percutaneous tracheostomy This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Laryngeal mask airway vs endotracheal tube to facilitate bedside percutaneous tracheostomy in critically ill patients: a prospective comparative study. This link exits the ClinicalTrials.gov site

Laryngeal Mask Airway or Endotracheal Tube for Percutaneous Dilatational Tracheostomy This link exits the ClinicalTrials.gov site

Endotracheal tube or laryngeal mask for airway control during percutaneous dilatational tracheostom This link exits the ClinicalTrials.gov site

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Responsible Party:	Elif Göktaş, Anesthesiology Resident, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier:	NCT04872881
Other Study ID Numbers:	eliftez
First Posted:	May 5, 2021 Key Record Dates
Last Update Posted:	May 5, 2021
Last Verified:	April 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Elif Göktaş, Bozyaka Training and Research Hospital:


Percutan Dilatational Tracheostomy Intensive Care Units

Additional relevant MeSH terms:

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Fentanyl Propofol Rocuronium Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics	Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents

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