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Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation (DISPOSITIF LAR)

Primary Purpose

Pharyngolaryngeal Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Insertion of LMA-UNIQUE(TM) device

Insertion of LMA-SUPREME(TM) device

Insertion of I-GEL(R) device

About this trial

This is an interventional treatment trial for Pharyngolaryngeal Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Adult patients > 18
ASA score I-III
Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
The patient is pregnant or breastfeeding
Emergency surgery
Sore thoat ≤ 1 month
Risk of aspiration of gastric contents
Body mass index (BMI) > 35
Patients with expected airway difficulties
Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
Patients who are not fasting for routine and emergency anesthesia
Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass

Sites / Locations

CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

LMA-UNIQUE™

LMA-SUPREME™

I-GEL®

Arm Description

Outcomes

Primary Outcome Measures

Incidence of pharyngolaryngeal postoperative pain of the three devices

Sore throat Y/N

Secondary Outcome Measures

Pharyngolaryngeal postoperative pain between groups

Sore throat Y/N

Time taken to place device

From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds)

Number of attempts needed to place device

Necessity of altering the size of the device

Y/N

Any patient movement during procedure

Y/N

Difficulty of insertion

5-point scale: very easy-failure

Total leakage pressure of the devices

measured directly by the respirator

Ventilatory pressure of the devices

Device stability during surgery

Need to change the management system airways (orotracheal intubation or others) Y/N

Difficulty of device removal

4-point scale: very easy-very difficult

Full Information

NCT ID

NCT03614598

First Posted

July 20, 2018

Last Updated

July 30, 2018

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT03614598

Brief Title

Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

Acronym

DISPOSITIF LAR

Official Title

Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 22, 2009 (Actual)

Primary Completion Date

September 5, 2012 (Actual)

Study Completion Date

September 5, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngolaryngeal Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

546 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LMA-UNIQUE™

Arm Type

Active Comparator

Arm Title

LMA-SUPREME™

Arm Type

Active Comparator

Arm Title

I-GEL®

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Insertion of LMA-UNIQUE(TM) device

Intervention Description

LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Intervention Type

Procedure

Intervention Name(s)

Insertion of LMA-SUPREME(TM) device

Intervention Description

LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Intervention Type

Procedure

Intervention Name(s)

Insertion of I-GEL(R) device

Intervention Description

I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Primary Outcome Measure Information:

Title

Incidence of pharyngolaryngeal postoperative pain of the three devices

Description

Sore throat Y/N

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Pharyngolaryngeal postoperative pain between groups

Description

Sore throat Y/N

Time Frame

2 hours

Title

Time taken to place device

Description

From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds)

Time Frame