Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices

Tracheal Intubation Clinical Trial

Official title:

Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346459
• Other study ID #: 11/11/2019anesthesia
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: June 2023
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares three different supraglottic airway devices used as a conduit for tracheal intubation in order το determine which one achieves the highest success rate of first attempt intubation

Description:

Prospective, randomized, comparative, clinical, controlled study, that is approved by the Ethics Commitee of the University of Patras (10.12.2019) and takes part in the University Hospital of Patras. Depending on the supraglottic airway device (SGA)/ laryngeal mask airway (LMA) used to achieve intubation (Fastrach, I-gel, Protector), partcipants will be randomly allocated into three groups; Group A, B and C (Fastrach, I-gel, Protector respectively).

In the preoperative setting, a complete preanesthetic evaluation will be performed, including a detailed airway assessment (prediction of difficulty in face mask ventilation, insertion of SGA/LMA and intubation).

All patients are scheduled to undergo an elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with FiO2 100% for at least 5 minutes. After induction, using rocuronium 0.6mg/kg to facilitate neuromuscular blockade, face mask ventilation follows.

1. Group A- Fastrach: The intubating laryngeal mask airway (Fastrach) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using its own endotracheal tube according to the blind technique insertion.

2. Group B- I-gel: The supraglottic airway device (I-gel) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.

3. Group C- Protector: The supraglottic airway device (Protector) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.

In all groups (A, B, C) up to 3 attempts of SGA/LMA placement and up to 3 attempts of intubation are allowed to be made.

In case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA/LMA placement, then the algorithm of the difficult airway will be immediately followed. Video-assisted laryngoscopy will be the first option rescue alternative.

The time of the whole procedure from the beginning of SGA's/LMA's placement effort until the successful intubation will be recorded, along with the evaluation of the success rate of first intubation attempt.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (age = 18 yrs) scheduled for an elective surgery under general anesthesia

• Written informed consent to participate in the trial

Exclusion Criteria:

• Age < 18 yrs

• Non- elective (urgent/ emergency) procedures or multi-trauma patients

• Obstetric population

• Surgery performed under regional anesthesia

• Contraindication to LMA insertion

• Predicted difficulty in LMA insertion (at least one out of four "RODS" criteria)

• Contraindication to the use of neuromuscular blockade or situations that require spontaneous breathing

• Indication for awake intubation or surgical airway

• Patients' involvement in another clinical trial

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Procedure:
• Tracheal intubation through "Fastrach" - Group A
Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device
• Tracheal intubation through "I-gel" - Group B
Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope
• Tracheal intubation through "Protector" - Group C
Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of intubation at first attempt	Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt	Up to study completion, an average of 2 years
Secondary	Time required for tracheal intubation	Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until the endotracheal tube is successfully placed confirmed by continuous waveform capnography (3 cycles)	Up to study completion, an average of 2 years
Secondary	Time required for successful supraglottic airway device/ laryngeal mask placement	Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until adequate ventilation is confirmed by continuous waveform capnography (3 cycles)	Up to study completion, an average of 2 years