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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

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.

Condition or disease Intervention/treatment
Airway Complication of Anesthesia Device: LMA Protector

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADEPT 1 - Observational Study of the LMA Protector
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Group/Cohort Intervention/treatment
LMA Protector
The LMA Protector will be used
Device: LMA Protector
The LMA Protector will be inserted when a supraglottic device is needed




Primary Outcome Measures :
  1. First go insertion success rate [ Time Frame: Day 1 ]
    Whether insertion during first go was successful or not

  2. First go successful ventilation rate [ Time Frame: Day 1 ]
    Whether ventilation during first go was successful or not

  3. Percentage of complication free insertions [ Time Frame: Day 1 ]
    Number of complication free insertions divided by total number of insertions


Secondary Outcome Measures :
  1. Time to first square capnography waveform [ Time Frame: Day 1 ]
    Record time in seconds of time to first capnography trace

  2. Lowest oxygen saturation level [ Time Frame: Day 1 ]
    Record lowest oxygen saturation reading

  3. Interventions needed to ensure airway patency [ Time Frame: Day 1 ]
    Collect number of predefined interventions needed to keep airway patent

  4. Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was visible chest movement

  5. Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was tidal volume > 7ml/kg

  6. Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was stable SpO2

  7. Quality of ventilation [ Time Frame: Day 1 ]
    The quality of ventilation will depend on whether there was square capnography trace

  8. 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

  9. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing operation under general anaesthesia with a supraglottic airway device
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664700


Contacts
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Contact: Jaideep Pandit +44(0)1865-221590 jaideep.pandit@sjc.ox.ac.uk

Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Royal United Hospital Bath NHS Trust
Royal Berkshire NHS Foundation Trust
Northampton General Hospital NHS Trust
University Hospital of Wales

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Responsible Party: Jaideep Pandit, Primary Investigator, Consultant Anaesthetist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03664700     History of Changes
Other Study ID Numbers: 1338
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jaideep Pandit, Oxford University Hospitals NHS Trust:
Supraglottic airway device
LMA Protector