Clinical Trial

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

Active, Not Recruiting
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Record status
This record was last updated February 28, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2016-04-13; most recent amendment 2025-02-25.
Status change: Recruiting → Active, Not Recruiting 2017-08-07
Trial Details
NCT Number NCT02738788
Lead Sponsor Tufts Medical Center
Conditions Airway Management
Enrollment 180 participants
Start Date 2015-05
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-28