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Observational Study of the LMA Protector (ADEPT1)

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ClinicalTrials.gov Identifier: NCT03664700
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Royal United Hospital Bath NHS Trust
Royal Berkshire NHS Foundation Trust
Northampton General Hospital NHS Trust
University Hospital of Wales
Information provided by (Responsible Party):
Jaideep Pandit, Oxford University Hospitals NHS Trust

Tracking Information
First Submitted Date July 26, 2018
First Posted Date September 10, 2018
Last Update Posted Date August 16, 2019
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2018)
  • First go insertion success rate [ Time Frame: Day 1 ]
    Whether insertion during first go was successful or not
  • First go successful ventilation rate [ Time Frame: Day 1 ]
    Whether ventilation during first go was successful or not
  • Percentage of complication free insertions [ Time Frame: Day 1 ]
    Number of complication free insertions divided by total number of insertions
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03664700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 7, 2018)
  • Time to first square capnography waveform [ Time Frame: Day 1 ]
    Record time in seconds of time to first capnography trace
  • Lowest oxygen saturation level [ Time Frame: Day 1 ]
    Record lowest oxygen saturation reading
  • Interventions needed to ensure airway patency [ Time Frame: Day 1 ]
    Collect number of predefined interventions needed to keep airway patent
  • Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was visible chest movement
  • Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was tidal volume > 7ml/kg
  • Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was stable SpO2
  • Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was square capnography trace
  • Complications occurrence during insertion of device, during anaesthesia, and on device removal [ Time Frame: Day 1 ]
    Collect number of pre-defined complications of device usage
  • Complications occurrence during insertion of device, during anaesthesia, and on device removal [ Time Frame: Day 2 ]
    Collect number of pre-defined complications of device usage
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of the LMA Protector
Official Title ADEPT 1 - Observational Study of the LMA Protector
Brief 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.
Detailed 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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing operation under general anaesthesia with a supraglottic airway device
Condition Airway Complication of Anesthesia
Intervention Device: LMA Protector
The LMA Protector will be inserted when a supraglottic device is needed
Study Groups/Cohorts LMA Protector
The LMA Protector will be used
Intervention: Device: LMA Protector
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 7, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jaideep Pandit +44(0)1865-221590 jaideep.pandit@sjc.ox.ac.uk
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03664700
Other Study ID Numbers 1338
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description:

Data will be collected prospectively on data collection sheets completed by the anaesthetist / investigator during anaesthesia. Each site will manage their own data set and the data will be pooled at the end of the recruitment phase across all sites. Data will be sent from sites to the lead study team only at the end of the data collection.

Consent form and initial data collection forms will be filed in the master folder and kept locked in the dedicated research locker in the department. The PI at each site will have access to this log. Each site will assign a study ID for each participant and a record of these IDs will be kept in the site file. Only anonymised data will be sent from each trust to the main study team. No personal data will be sent to the coordinating centre.

Responsible Party Jaideep Pandit, Oxford University Hospitals NHS Trust
Study Sponsor Oxford University Hospitals NHS Trust
Collaborators
  • Royal United Hospital Bath NHS Trust
  • Royal Berkshire NHS Foundation Trust
  • Northampton General Hospital NHS Trust
  • University Hospital of Wales
Investigators Not Provided
PRS Account Oxford University Hospitals NHS Trust
Verification Date August 2019