|- candidate number||14662|
|- NTR Number||NTR3931|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-apr-2013|
|- Secondary IDs||U1111-1139-5694 |
|- Public Title||Baska mask versus Proseal laryngeal mask for reduction of laryngopharyngeal morbidity following elective surgery.|
|- Scientific Title||Impact of supraglottic airway device cuff pressure on the incidence of laryngopharyngeal morbidity following elective surgery under general anesthesia in young adults: Comparison of classic and Proseal laryngeal mask versus the Baska mask.|
|- ACRONYM||BLAM Trial (Baska mask versus classic and Proseal LAryngeal mask for reduction of laryngopharyngeal Morbidity following elective surgery)|
|- hypothesis||We hypothesize that low pressure supraglottic device like the cuffless Baska mask is associated with lesser postoperative laryngopharyngeal morbidity following elective surgery under general anaesthesia as compared to the cuffed Laryngeal mask Airways.|
|- Healt Condition(s) or Problem(s) studied||General anesthesia, Supraglottic airway device|
|- Inclusion criteria||1. Patients who give informed consent;|
2. Elective ambulatory surgery with an estimated duration of 30 to 60 minutes;
3. American Society of Anesthesiologists (ASA) status I-II;
4. Aged 18 to 50 years;
5. Body mass index (BMI) ≤ 35 kg/m2.
|- Exclusion criteria||1. Predictors of or a history of difficult intubation;|
2. Immobilized cervical spine;
3. A history of uncontrolled gastroesophageal reflux or hiatus hernia;
4. Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-apr-2013|
|- planned closingdate||15-sep-2013|
|- Target number of participants||150|
|- Interventions||Arm 1: Baska Mask Group;|
Arm 2: Cuffed Airway Group (PLM).
|- Primary outcome||Sore throat score following the use of SADs.
(Score 0 = no complaints, score 1 = minimal sore throat, score 2 = moderate sore throat, score 3 = severe sore throat: "never a SAD again").|
|- Secondary outcome||1. Insertion time needed for placement of the SAD;|
2. Number of attempts needed to correctly place the SAD;
3. Airway Sealing Pressure in cm H2O at 5 and 10 mins post-placement;
4. Ease of removal;
5. Blood on the device;
6. Duration for which the device remained in the oropharynx.
|- Timepoints||Sore throat will be assessed after the operation as well as on the next postoperative day.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Naresh Kaul|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Rashid M. Khan|
|- Sponsor/Initiator ||Ministry of Health, Oman|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Oman|
|- Brief summary||Background: |
Patients coming for surgical procedures on the day of surgery and leaving the hospital before the end of the day is gaining popularity. This is popularly called as Day Care Surgery or Ambulatory Surgery. Administration of general anesthesia to these patients may necessitate that their breathing passages remain patent and safely connected to anesthesia machine at all times during surgery. This is usually achieved by placing a tube with a cup at its distal end in the patient’s mouth. This cup has an inflatable rim to make a seal around the proximal opening of the patient’s breathing passage (trachea) called the glottis. Such a device is called supraglottic device as it is placed above the glottis. Laryngeal mask airway (cLMA) or its variant called the Proseal laryngeal mask (PLM) are the most commonly used supraglottic device during day care surgery.
Despite cLMA’s safety profile, the incidence of sore throat following the use of cLMA has been reported to be five times more than that with face mask when used in ambulatory surgery. This is mainly attributed to the pressure exerted by the inflatable cuff inside the mouth. A previous study in ambulatory surgical patients found postoperative sore throat in 9% and 10% of patients managed with a cLMA and PLM respectively.
Aim of the Present Study:
Being without an inflatable cuff, the problem of sore throat due to excessive cuff pressure as observed with PLM is expected to be significantly reduced with the use of Baska Mask (BM) which is the most recently introduced supraglottic device in 2012. For the same reason, use of the BM should neither cause tissue trauma nor nerve damage.
The association between extended postoperative stay following day care ambulatory surgery under general anesthesia could be the result of discomfort from a sore throat early in the postoperative period making patients reluctant to go home.
We hypothesize that patients undergoing ambulatory day care surgery using BM will be associated with a reduced incidence of laryngopharyngeal morbidity as compared to following a standard, uniform general anesthetic technique.
Who can participate?
All patients coming for ambulatory surgery under general anesthesia needing a supraglottic device to maintain patency of their breathing passage can participate in this trial after expressing their verbal consent.
What does the study involve? In this study we plan to assess whether using a BM in place of PLM shall decrease the incidence of sore throat, difficulty in swallowing or speaking after the end of anesthesia and surgery leading to an early patient discharge from the hospital.
Patients shall be randomly divided into 2 groups. Patients of group A shall have their airway passages secured using a PLM while group B patients shall have BM as the supraglottic device during the surgical procedure.
What are the possible benefits and risks of participating?
The outcome of this trial shall benefit patients coming for ambulatory surgery whose breathing passages needs to be secured by a supraglottic device during anesthesia and surgery by having a lesser incidence of sore throat leading to an early discharge. There are no added risks that can be attributed to the intervention.
Where is the study run from?
The study shall be run at two different centers. They are: Department of Anesthesia & ICU, Khoula Hospital, Muscat, Sultanate of Oman and Department of Medicine, Jawahar Lal Nehru Medical College, Aligarh, India. The lead center would be Department of Anesthesia & ICU, Khoula Hospital, Muscat, Sultanate of Oman.
When is the study starting and how long is it expected to run for?
We have already received approval from the Ethical Issues Committee of the hospital. We plan to commence data collection from mid March 2013. We expect that the Pilot study should be completed within 4-6 weeks. However, the larger study may be expected to run for about 6-7 months.
Who is funding the study?
The two authors (Rashid M Khan & Naresh Kaul) have secured the requisite number of BM from the market. The other devices (PLM) needed for the study is freely available in the operation theatres of both institutions and needs no funding.
Who is the main contact?
The main contact would be Dr. Naresh Kaul, Senior Consultant, Department of anesthesia & ICU, Khoula Hospital, Muscat, Sultanate of Oman. E-mail: firstname.lastname@example.org; email@example.com
|- Main changes (audit trail)|
|- RECORD||2-apr-2013 - 19-apr-2013|