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Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique

Study acronym: LEPAGA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Jun 1, 2026 to Jun 1, 2028v18
  2. Notable Primary and study completion dates: Jun 1, 2025 to Jun 1, 2026v17
  3. Minor Site contact updatedv16
  4. Minor Primary completion date: Jan 1, 2025 to Jun 1, 2025
    • Site contact updated
    • Publications: details revised at 17 of 17 entries
    v15
  5. Minor Site contact updated
    • Publications: details revised at 17 of 17 entries
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Notable Primary completion date: Jan 1, 2024 to Jan 1, 2025
    • Study completion date: Jun 1, 2024 to Jun 1, 2025
    v13
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Jul 1, 2023 to Jan 1, 2024
    • Study completion date: Jan 1, 2024 to Jun 1, 2024
    • Site details revised
    v12
  3. Notable Primary completion date: Jul 1, 2022 to Jul 1, 2023
    • Study completion date: Jan 1, 2023 to Jan 1, 2024
    v11
  4. Notable Primary completion date: Jul 1, 2021 to Jul 1, 2022
    • Study completion date: Jan 1, 2022 to Jan 1, 2023
    v10
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 140 to 130
    • Site details revised
    v9
  6. Notable Primary completion date: Jan 1, 2021 to Jul 1, 2021
    • Start date: Jan 1, 2019 to Jan 1, 2020
    • Study completion date: Jan 1, 2021 to Jan 1, 2022
    v8
  7. Notable Primary and study completion dates: Jan 1, 2019 to Jan 1, 2021
    • Start date: Jan 1, 2018 to Jan 1, 2019
    v7
  8. Minor Re-verified, no change to tracked fieldsv6
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 1, 2018 to Jan 1, 2019
    • Start date: May 1, 2017 to Jan 1, 2018
    • Study sites: 0 to 1
    v5
  10. Notable Primary and study completion dates: Mar 2017 to May 1, 2018
    • Start date: Mar 2016 to May 1, 2017
    • Study description expanded, about 16 words
    v4
  11. Minor Re-verified, no change to tracked fieldsv3
  12. Minor Interventions: Emergence from anesthesia (Procedure), Induction of anesthesia (Procedure), Intubation of the trachea through the LMA (Procedure)… to Emergence from anesthesia (Procedure), Induction of anesthesia (Procedure), Intubation of the trachea through the LMA (Procedure)…v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia. Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway. The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.
Trial Details
NCT Number NCT02708836
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: Ambu A/S
Conditions
(from sponsor)
Limit Emergence Phenomena After General Anesthesia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov