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Airway Changes in Patients Undergoing Elective Surgical Procedures in the Prone and Trendelenburg Positions

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2025 → Dec 31, 2027
See other at-risk trials from Tufts Medical Center

Record History

  1. Primary completion pushed from Dec 31, 2025 to Dec 31, 2027 Completion pushed from Jul 31, 2026 to Jul 31, 2028 · Start date: May 2015 to May 22, 2015 · Study description revised · 1 more Show 4 more changesShow less
    • Completion pushed from Jul 31, 2026 to Jul 31, 2028
    • Start date: May 2015 to May 22, 2015
    • Study description revised
    • Eligibility criteria expanded, about 2 words
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025 Completion date: Jul 31, 2025 to Jul 31, 2026v12 Show 1 more changeShow less
    • Completion date: Jul 31, 2025 to Jul 31, 2026
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2024 Completion date: Jul 31, 2024 to Jul 31, 2025v11 Show 1 more changeShow less
    • Completion date: Jul 31, 2024 to Jul 31, 2025
  4. Primary completion date: Dec 2022 to Dec 31, 2023 Completion date: Jul 2023 to Jul 31, 2024v10 Show 1 more changeShow less
    • Completion date: Jul 2023 to Jul 31, 2024
  5. Primary completion date: Dec 2021 to Dec 2022 Completion date: Jul 2022 to Jul 2023v9 Show 1 more changeShow less
    • Completion date: Jul 2022 to Jul 2023
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jan 2021 to Dec 2021 Completion date: Dec 2021 to Jul 2022v8 Show 1 more changeShow less
    • Completion date: Dec 2021 to Jul 2022
  2. Primary completion date: Dec 2019 to Jan 2021 Completion date: Dec 2019 to Dec 2021v7 Show 1 more changeShow less
    • Completion date: Dec 2019 to Dec 2021
  3. Primary and study completion dates: Dec 2018 to Dec 2019v6
  4. Primary completion date: May 2018 to Dec 2018 Completion date: Jul 2018 to Dec 2018v5 Show 1 more changeShow less
    • Completion date: Jul 2018 to Dec 2018
  5. Primary completion date: May 2017 to May 2018 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jul 2017 to Jul 2018 · Site details revisedv4 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jul 2017 to Jul 2018
    • Site details revised
  6. Re-verified, no change to tracked fieldsv3
  7. Study description shortened, about 65 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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 goal of this study is to track the intraoperative changes that occur in the airways of patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal surgeries in the prone position, as well as the regression of these changes postoperatively. These surgeries are known to cause edema and swelling of the soft tissues of the head and neck, temporarily worsening airway anatomy, but there is little data quantifying these changes, and no studies have investigated the time course required for the airway to return to its baseline after extubation. This would be important clinical information given that airway management is always a major concern perioperatively. The investigators will test hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of a difficult intubation) based on the visibility of the soft palate, uvula, and faucial pillars inside the oral cavity.
Trial Details
NCT Number NCT02738788
Lead Sponsor Tufts Medical Center
Conditions Airway Management
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov