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Structural Modification In Supraglottic Airway Device

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 64 participants (planned 100)
    • Primary completion date changed from estimate of Aug 24, 2026 to Feb 24, 2026
    • Interventions: A/Z Supraglottic airway (Device) to A/Z Supraglottic airway (Device)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Primary and study completion pushed from Feb 24, 2026 to Aug 24, 2026
    • Site contact updated
    v13
  3. Primary and study completion dates: Dec 31, 2025 to Feb 24, 2026
    • Site contact updated
    v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v9
  2. Primary and study completion dates: Jun 30, 2023 to Dec 31, 2023v8
  3. Primary and study completion dates: Jun 30, 2022 to Jun 30, 2023v7
  4. Trial status: Suspended to Recruiting
    • Primary and study completion dates: Jun 30, 2021 to Jun 30, 2022
    • Site details revised
    v6
  5. Trial status: Recruiting to Suspended Sponsor's reason: The manufacturer of the device has pending modifications to the device. Enrollment will resume once the revised devices are received at the…
    • Site details revised
    v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  7. Start date: Aug 30, 2020 to Sep 30, 2020v3
  8. Start date: Jul 30, 2020 to Aug 30, 2020v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.
Trial Details
NCT Number NCT04498598
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Airway Complication of Anesthesia, Ventilation Therapy; Complications, Hypoxia, Hypoventilation
Related terms Hypoventilation, Hypoxia, Respiratory Aspiration
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov