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

NCT ID: NCT03852589

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-04-01

Brief Summary

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.

Detailed Description

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.

Conditions

Laryngeal Masks; Anesthesia, General; Videolaryngoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

C-MAC Videolaryngoscope

C-MAC Videolaryngoscope: An intubating device that is used for endotracheal intubation. Proseal laryngeal mask airway will be inserted with C-MAC Videolaryngoscope

Group Type: ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type: DEVICE

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

Blind

Proseal laryngeal mask airway will be inserted with digital finger

Group Type: ACTIVE_COMPARATOR

Blind

Intervention Type: DEVICE

PLMA will inserted by anesthesiologist with digital finger.

Interventions

C-MAC videolaryngoscope

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

Intervention Type: DEVICE

Blind

PLMA will inserted by anesthesiologist with digital finger.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Ülkü Özgül

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulku Ozgul

Role: PRINCIPAL_INVESTIGATOR

Inonu University Faculty of Medicine

Locations

Inonu University

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Koay CK, Yoong CS, Kok P. A randomized trial comparing two laryngeal mask airway insertion techniques. Anaesth Intensive Care. 2001 Dec;29(6):613-5. doi: 10.1177/0310057X0102900609.

Reference Type: BACKGROUND

PMID: 11771605 (View on PubMed)

Sorbello M, Petrini F. Supraglottic Airway Devices: the Search for the Best Insertion Technique or the Time to Change Our Point of View? Turk J Anaesthesiol Reanim. 2017 Apr;45(2):76-82. doi: 10.5152/TJAR.2017.67764. Epub 2017 Apr 1.

Reference Type: BACKGROUND

PMID: 28439437 (View on PubMed)

Ozgul U, Erdil FA, Erdogan MA, Begec Z, Colak C, Yucel A, Durmus M. Comparison of videolaryngoscope-guided versus standard digital insertion techniques of the ProSeal laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2019 Dec 30;19(1):244. doi: 10.1186/s12871-019-0915-3.

Reference Type: DERIVED

PMID: 31888511 (View on PubMed)

Other Identifiers

UlkuVL

Identifier Type: -

Identifier Source: org_study_id