Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

NCT02063516 | Completed Results DMC

• 1 other identifier: Wang001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Conditions

Efficacy of Oropharyngeal Seal Pressure

Keywords

Airway Cuff; Guardian; Proseal; Cuff Pressure; laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal Seal Pressure

  This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

  5 min

Secondary Outcomes (1)

• Anatomic Position

  5 min

Other Outcomes (1)

• Amount of Air Added to Keep Cuff Pressure 60cmH20.

  30 minutes, 60 minutes, 90 minutes and 120 minutes

Study Arms (2)

Guardian

EXPERIMENTAL

Device: Guardian Laryngeal Mask

Device: Guardian Laryngeal Mask

Proseal

EXPERIMENTAL

Device:Proseal Laryngeal Mask Airway

Device: Proseal Laryngeal Mask Airway

Interventions

Guardian Laryngeal Mask DEVICE

Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.

Guardian

Proseal Laryngeal Mask Airway DEVICE

Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube

Proseal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age
• Mallampati score less than 3
• thyromental distance more than 6.5 cm
• mouth opening more than \>2.5 cm
• a body mass index less than 35 kg/m2;

You may not qualify if:

• Body weight 50 Kg
• Pregnancy
• Difficult airway
• Recent history of upper respiratory tract infection and sore throats
• A history of esophageal reflux disease
• ENT surgery
• Laparoscopic surgery
• Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (1)

• Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.

  PMID: 25929558 DERIVED

Limitations and Caveats

We only use size-4 devices in adult patients with neuromuscular blockade, we presumed that same results would be obtained in patients who have not received neuromuscular blockade. lastly our data was not blinded causing potential source of bias.

Results Point of Contact

• Title: Dr. Haiyun Wang
• Organization: tianjinMUGH

wanghy819@hotmail.com

008613752211206

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-Professor

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: February 14, 2014
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 26, 2015
• Results First Posted: December 18, 2014

Record last verified: 2014-12

Locations

CN (1)