Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03664700
Other study ID # 1338
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 5, 2019
Est. completion date August 1, 2021

Study information

Verified date October 2021
Source Oxford University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators want to investigate the user friendliness, and performance of the LMA Protector. The principal research question is to assess the overall performance of the LMA Protector. The investigators are merely making observations related to use of the device during clinical practice.


Description:

There is a lack of research data on regarding the use of the LMA Protector. There is no regulatory requirement to collect or publish patient data on any device, either before CE marking or after. These devices are freely purchased and used. There is, however, a professional duty to know that a device conforms to established norms for use. These norms are not official standards but rather, reference data against which a device can be clinically judged. Therefore, a device that is easy to insert but has a low 'leak pressure' (see above) is different from one that is more difficult to insert but as a high leak pressure. It is not that one is 'better' than the other, but rather that the data help create a 'usability profile' of the device which can be useful when making a clinical selection for the device. Preoperative assessment: During the preoperative visit, patient information leaflet will be given to the patients meeting the eligibility criteria. Wherever possible, suitable patients will be identified in the preoperative assessment clinic and the information leaflet given. The patients will be given adequate time to read this information and any queries will be answered before being asked to sign a consent form. A detailed airway assessment will be performed by one of the investigators and documented on the study proforma. Induction of anaesthesia: On arrival in the anaesthetic room patients will be monitored with pulse oximetry, electrocardiography and invasive or non-invasive blood pressure measurements. After intravenous access is secured and the pre-surgical checklist completed, all patients will be pre-oxygenated using a facemask to achieve end tidal oxygen concentration of at least 80%. A 'sniffing' position of the head and neck and a 20 degree head-up bed tilt will be used for pre-oxygenation. General anaesthesia will be induced intravenously. After induction of anaesthesia, facemask ventilation will be commenced and anaesthesia maintained with an inhalational anaesthetic agent in oxygen or with total intravenous anaesthesia. The volatile agent's (anesthetic gases) concentration of 1 MAC adjusted for the patient's age will be achieved and maintained. This is normal process of anaesthesia applicable for all patients irrespective of participation in the study. Supraglottic airway device (SAD) insertion: Once deep plane of anaesthesia is confirmed, with the absence of movement to jaw thrust stimulation the SAD (LMA protector) will be inserted. The size of the device will be based on the manufacturer's recommendations for the body weight. The breathing system will be connected to the device. Ventilation of the lungs will be then confirmed by observing adequate bilateral chest inflation and square end-tidal capnogram wave with positive pressure ventilation. Adequate ventilation will be recorded if three tests are passed: 1) adequate chest movement, 2) an expired tidal volume of at least 7 ml/kg and 3) stable oxygenation. Time would continue until LMA® ProtectorTM inserted successfully. If it is not possible to insert the device or ventilate through it, two more attempts at placement of the device will be allowed. If placement has failed after two further attempts, the study will be abandoned and the other device will be used. If this fails on first attempt a different LMA or tracheal tube will be used as appropriate. Maintenance of anaesthesia and recovery The main interventions refer to the insertion of the airway device into the patient to obtain a airway and allow the conduct of the anaesthetic and therefore the surgery. However, if there are problems with the device and the airway obtained is suboptimal then the below interventions are allowed (which will be noted in the data collection form): 1. Neck extension - move patient's neck upward 2. Neck flexion - move patient's neck downward 3. Chin lift - manoeuvre to open the airway 4. Jaw thrust - manoeuvre to open the airway 5. Reposition of the device At the end of operation, anaesthetic agents will be discontinued while the device is left in place. The device will be removed after the patient has regained consciousness, and has responded to verbal command to open the mouth. Any complications that occur during the use of the device will be recorded. Postoperative assessment Postoperatively in recovery or on the ward, the investigators will visit each patient and determine whether the following airway complications are present after surgery: sore throat (constant pain, independent of swallowing), dysphagia (difficulty in, or pain provoked by, swallowing), sore jaw, dysphonia (difficulty in, or pain on, speaking), numbness of the tongue or the oropharynx, ear pain, neck or mouth ache, hearing changes. Each complication will be graded as none, mild, moderate or severe. The same questions will be asked 24-48 hours later. First visit During the first visit by the anaesthetist to the participant, at the anaesthetist's earliest opportunity, either in the recovery area or on the ward, the participants will be asked about the following complications, which will be graded as none, mild, moderate or severe. 1. Vomiting 2. Lip or tongue swelling 3. Hearing changes 4. Ear pain 5. Sore throat 6. Pain on swallowing 7. Jaw pain 8. Neck or mouth ache 9. Pain on speaking 10. Numbness of the tongue Second visit (or telephone consultation) During the second visit 24-48 hours post-operatively on the ward or via telephone the participants will be asked about the following complications, which will be graded as none, mild, moderate or severe. 1. Vomiting 2. Lip or tongue swelling 3. Hearing changes 4. Ear pain 5. Sore throat 6. Pain on swallowing 7. Jaw pain 8. Neck or mouth ache 9. Pain on speaking 10. Numbness of the tongue


Recruitment information / eligibility

Status Terminated
Enrollment 120
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - Adult participants who are having a general anaesthetic. - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. - ASA 1 - 3 category patients - Elective operations - Urgent operations - Patients suitable for an SAD based on patient and operation factors. Exclusion Criteria The participant may not enter the study if ANY of the following apply: - Refusal of consent - Age less than 18 years - Require intubation for the operation - Risk of regurgitation - ASA 4 and above - Mouth opening less than 2.5cm Require awake intubation

Study Design


Related Conditions & MeSH terms

  • Airway Complication of Anesthesia

Intervention

Device:
LMA Protector
The LMA Protector will be inserted when a supraglottic device is needed

Locations

Country Name City State
United Kingdom Royal United Hospital Bath
United Kingdom Aneurin Bevan University Health Board Cardiff
United Kingdom Nothampton General Hospital Northampton
United Kingdom Oxford University Hospitals Oxford
United Kingdom Royal Berkshire Hospital Reading

Sponsors (5)

Lead Sponsor Collaborator
Oxford University Hospitals NHS Trust Northampton General Hospital NHS Trust, Royal Berkshire NHS Foundation Trust, Royal United Hospital Bath NHS Trust, University Hospital of Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary First go insertion success rate Whether insertion during first go was successful or not Day 1
Primary First go successful ventilation rate Whether ventilation during first go was successful or not Day 1
Primary Percentage of complication free insertions Number of complication free insertions divided by total number of insertions Day 1
Secondary Time to first square capnography waveform Record time in seconds of time to first capnography trace Day 1
Secondary Lowest oxygen saturation level Record lowest oxygen saturation reading Day 1
Secondary Interventions needed to ensure airway patency Collect number of predefined interventions needed to keep airway patent Day 1
Secondary Quality of ventilation The quality of ventilation will depend on whether there was visible chest movement Day 1
Secondary Quality of ventilation The quality of ventilation will depend on whether there was tidal volume > 7ml/kg Day 1
Secondary Quality of ventilation The quality of ventilation will depend on whether there was stable SpO2 Day 1
Secondary Quality of ventilation The quality of ventilation will depend on whether there was square capnography trace Day 1
Secondary Complications occurrence during insertion of device, during anaesthesia, and on device removal Collect number of pre-defined complications of device usage Day 1
Secondary Complications occurrence during insertion of device, during anaesthesia, and on device removal Collect number of pre-defined complications of device usage Day 2
See also
  Status Clinical Trial Phase
Recruiting NCT04498598 - Structural Modification In Supraglottic Airway Device N/A
Completed NCT04569539 - The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester. N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Recruiting NCT05657028 - Dexmedetomidine Versus Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients N/A
Completed NCT04546087 - Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height N/A
Completed NCT03395782 - Factors Determining Oxygen Wash in During Pre-oxygenation
Completed NCT03723109 - Airway Management During TCI vs RSI Anesthesia Induction
Recruiting NCT05899868 - Utilization of Airway Stabilizing Rod N/A
Completed NCT03613103 - Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation N/A
Completed NCT04138121 - Impact of Change of Head and Neck Position on Cricothyroid Membrane Localization and Membrane Height in Parturient Patients N/A
Not yet recruiting NCT03361397 - Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion N/A
Recruiting NCT03366311 - TCHCCT-Zhong-Xing-Emergency-Department-airway N/A
Completed NCT04196582 - LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography N/A
Completed NCT05769842 - Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy N/A
Completed NCT05106478 - AuraGain Performance in Lateral Position
Completed NCT04677894 - Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery
Completed NCT03547193 - Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy
Completed NCT04833166 - Comparing Full vs. Partial Glottis View Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient N/A
Recruiting NCT05680909 - Evaluation of SaCo Videolaryngeal Mask Airway in Morbidly Obese
Recruiting NCT06403696 - Predicting Post-op Airway Complications in Pediatric Patients Using Ultrasonography