NCT03852589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

February 22, 2019

Last Update Submit

April 8, 2019

Conditions

Laryngeal MasksAnesthesia, GeneralVideolaryngoscopy

Keywords

Airway managementVideolaryngoscopyGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

    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.

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

Secondary Outcomes (4)

  • Insertion time

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

  • Adverse Events

    During the first 24 hour postoperatively

  • Fiberoptic Score

    After the PLMA insertion up to 5 minutes

  • Airway Sealing Pressure

    After the PLMA insertion up to 5 minutes

Study Arms (2)

C-MAC Videolaryngoscope

ACTIVE COMPARATOR

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

Device: C-MAC videolaryngoscope

Blind

ACTIVE COMPARATOR

Proseal laryngeal mask airway will be inserted with digital finger

Device: Blind

Interventions

C-MAC videolaryngoscopeDEVICE

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

C-MAC Videolaryngoscope
BlindDEVICE

PLMA will inserted by anesthesiologist with digital finger.

Blind

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 11771605BACKGROUND

  • 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.

    PMID: 28439437BACKGROUND

  • 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.

    PMID: 31888511DERIVED

Study Officials

  • Ulku Ozgul

    Inonu University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 25, 2019

Study Start

March 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)