Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

NCT04872881 | Unknown Phase 4 DMC

• 1 other identifier: eliftez
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation, Intratracheal; Tracheostomy; Laryngeal Masks; Intensive Care Units

Keywords

Percutan Dilatational Tracheostomy; Intensive Care Units

Outcome Measures

Primary Outcomes (11)

• Arterial Blood Gas Analysis

  Monitoring of hypoxia, acidosis, and carbon dioxide

  Before the procedure

• Arterial Blood Gas Analysis

  Monitoring of hypoxia, acidosis, and carbon dioxide

  3rd minute after ventilation

• Arterial Blood Gas Analysis

  Monitoring of hypoxia, acidosis, and carbon dioxide

  6th minute after ventilation

• Arterial Blood Gas Analysis

  Monitoring of hypoxia, acidosis, and carbon dioxide

  10th minute after ventilation

• Arterial Blood Gas Analysis

  Monitoring of hypoxia, acidosis, and carbon dioxide

  When the tracheostomy cannula cuff is inflated

• Positioning time

  By placing a transverse elevation under the shoulders, the patients' neck will be extended as approprite.

  Before the procedure

• The Reposition Time

  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".

  Before the procedure

• The LMA Insertion Time

  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"

  Before the procedure

• Duration of the Confirmation of the Incision Site

  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

  Before the procedure

• Preparation Time

  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

  Before the procedure

• Procedure Time

  "Procedure Time" will start with skin incision and end with successful ventilation after tracheostomy cannula cuff is inflated.

  15 minutes after the procedure begins

Secondary Outcomes (7)

• Incidence of gastric distension

  Throughout the tracheostomy procedure

• Incidence of hypoxia

  Throughout the tracheostomy procedure

• Incidence of regurgitation

  Throughout the tracheostomy procedure

• The number of staff needed

  Throughout the tracheostomy procedure

• Heart rate

  Every 3 minutes during the procedure

Study Arms (2)

ETT Group

ACTIVE COMPARATOR

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; 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

LMA Group

ACTIVE COMPARATOR

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; 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

Interventions

Endotracheal Tube Insertion PROCEDURE

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

ETT Group

Laryngeal Mask Insertion PROCEDURE

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

LMA Group

Fiberoptic Bronchoscopy PROCEDURE

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.

ETT Group; LMA Group

Radial Artery Monitoring PROCEDURE

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

ETT Group; LMA Group

Anteroposterior chest x-ray DIAGNOSTIC_TEST

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

ETT Group; LMA Group

Arterial Blood Gas Analyses DIAGNOSTIC_TEST

Hypoxia, acidosis and carbon dioxide increase will be followed

ETT Group; LMA Group

Propofol Fresenius DRUG

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

ETT Group; LMA Group

Rocuronium DRUG

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

Also known as: Muscuron

ETT Group; LMA Group

Fentanyl DRUG

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

ETT Group; LMA Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Related Links

• Laryngeal mask airway vs endotracheal tube to facilitate bedside percutaneous tracheostomy in critically ill patients: a prospective comparative study.
• Laryngeal Mask Airway or Endotracheal Tube for Percutaneous Dilatational Tracheostomy

MeSH Terms

Interventions

Intubation, Intratracheal; Propofol; Rocuronium; Fentanyl

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Elif Göktaş

CONTACT

05062073485; e.goktas44@hotmail.com

Zeki T TEKGUL

CONTACT

05073341373; zekittekgul@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Model Details: There are two groups: ETT Group and LMA Group

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 5, 2021
• Study Start: May 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-04