Pharyngolaryngeal Postoperative Pain Clinical Trial
— DISPOSITIF LAROfficial title:
Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
| Verified date | July 2018 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%
| Status | Completed |
| Enrollment | 546 |
| Est. completion date | September 5, 2012 |
| Est. primary completion date | September 5, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Nimes | Nîmes |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of pharyngolaryngeal postoperative pain of the three devices | Sore throat Y/N | 24 hours | |
| Secondary | Pharyngolaryngeal postoperative pain between groups | Sore throat Y/N | 2 hours | |
| Secondary | Time taken to place device | From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds) | End of surgery (maximum 2 hours) | |
| Secondary | Number of attempts needed to place device | End of surgery (maximum 2 hours) | ||
| Secondary | Necessity of altering the size of the device | Y/N | End of surgery (maximum 2 hours) | |
| Secondary | Any patient movement during procedure | Y/N | End of surgery (maximum 2 hours) | |
| Secondary | Difficulty of insertion | 5-point scale: very easy-failure | End of surgery (maximum 2 hours) | |
| Secondary | Total leakage pressure of the devices | measured directly by the respirator | End of surgery (maximum 2 hours) | |
| Secondary | Ventilatory pressure of the devices | End of surgery (maximum 2 hours) | ||
| Secondary | Device stability during surgery | Need to change the management system airways (orotracheal intubation or others) Y/N | End of surgery (maximum 2 hours) | |
| Secondary | Difficulty of device removal | 4-point scale: very easy-very difficult | End of surgery (maximum 2 hours) |