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NCT Number: NCT04346459

Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

About this study

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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracheal intubation through "Fastrach" - Group A

Procedure

Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device

Tracheal intubation through "I-gel" - Group B

Procedure

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

Procedure

Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope

Primary outcomes

  1. Success rate of intubation at first attempt

    Time frame: Up to study completion, an average of 2 years

    Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt

Secondary outcomes

  1. Time required for tracheal intubation

    Time frame: Up to study completion, an average of 2 years

    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)

  2. Time required for successful supraglottic airway device/ laryngeal mask placement

    Time frame: Up to study completion, an average of 2 years

    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)

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2020
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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