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Completed

NCT Number: NCT03852589

The Effect of Placement of Proseal Laryngeal Mask Airway With C-Mac Videolaryngoscopy

The ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. The manufacturer recommends inserting the ProSealTM LMA using digital manipulation or with an introducer tool, but both these techniques have lower success rates than the classic LMA.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44090, Turkey (Türkiye)

About this study

Airway management is one of the cornerstones for modern anaesthesia and is vital for all patients undergoing general anaesthesia. Supraglottic airway devices (SADs) are increasingly used for managing airways.

The ProSeal laryngeal mask airway (PLMA) (Laryngeal Mask Company, San Diego, CA, USA) is a supraglottic airway device with a larger cuff than the Classic laryngeal mask airway to produce a better seal. The PLMA is also equipped with a drainage tube to permit insertion of a gastric tube and evacuation of gastric content. The presence of the drainage tube reduces the risk of aspiration, which is the major concern of the Classic laryngeal mask airway, especially when the device is used with positive pressure ventilation. While a dedicated introducer (commonly known as an ''introducer tool'') is recommended by the manufacturer to facilitate insertion of the PLMA, difficulties can still be encountered during insertion. The PLMA insertion success rate at first attempt has been reported as 82-87%, which is lower than the insertion success rate of the Classic laryngeal mask airway.

Malpositioning of the PLMA is common in clinical practice because its soft cuff can fold over onto itself. Malpositioning of the device can result in severe leaks and even obstruction of the airway, with potentially negative outcomes for the patient. Although the incidence of complications(e.g. airway trauma, obstruction, regurgitation, gastric distension with mechanical ventilation) is likely to be higher with an incorrectly placed SAD, clinical airway obstruction can result from other causes, such as laryngospasm and transient closure of the glottis.

Many methods have been proposed to facilitate insertion of PLMAs, including insertion of a gastric tube,a suction catheter, or a gum elastic bougie into the drainage tube. These techniques help to prevent the PLMA soft cuff from folding over and help to decrease the incidence of malpositioning.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18- 65 years
  • Undergoing short surgical prcedures with general anesthesia using a PLMA
  • American Society of Anesthesiology score I-II

Exclusion criteria

  • Anticipated difficult airway
  • Risk of aspiration
  • Patients who refused written informed consent forms

Treatment and study plan

C-MAC videolaryngoscope

Device

An intubating device that is used for endotracheal intubation. PLMA will inserted by anesthesiologist with C-MAC videolaryngoscope.

Blind

Device

PLMA will inserted by anesthesiologist with digital finger.

Primary outcomes

  1. First attempt success rate

    Time frame: From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes

    The PLMA will inserted into hypopharynx, the cuff will inflated with an appropraite volume of air. An effective airway will judged by a square wave on capnography.

Secondary outcomes

  1. Insertion time

    Time frame: From inserted PLMA to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

    Insertion time was the time between picking up the PLMA and successful placement

  2. Adverse Events

    Time frame: During the first 24 hour postoperatively

    Blood on the surface of the cuff, laryngospasm, hypoxia, hoarseness,sore throat

  3. Fiberoptic Score

    Time frame: After the PLMA insertion up to 5 minutes

    Fiberoptic view of PLMA placement through the airway tube was graded on a scale from 4 (best view) to 1 (worst view)

  4. Airway Sealing Pressure

    Time frame: After the PLMA insertion up to 5 minutes

    Fresh gas flow was adjusted to 3 L/min, and after closing the expiratory valve, the airway pressure at which an audible leak in the mouth was heard will recorded

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Comparison of C-MAC Videolaryngoscopy-guided Proseal Laryngeal Mask Airway Placement vs Conventional Blind Technique: a Prospective Randomized Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Apr 9, 2019

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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