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

NCT02738788 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Airway Management

Interventions

OTHER

Intubation

The patient's airway will be visually assessed and photographed while the patient is resting comfortable in bed with the head up at 30-45 degrees and classified into one of 4 MMS categories. Digital photographs will be taken and the stored image prepared by the investigators in such a way that the patient cannot be individually identified (mouth only). Neck circumference will be measured at the level of the thyroid cartilage using a tape measure, with temporary ink marks on the skin to allow for subsequent measurements at the same point. After the patient has been extubated and recovered in the PACU for 30 minutes, their airway will be re-assessed and documented. These evaluations will be repeated at 2, 3, and 4 hours, as well as the next morning.

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2025-12-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738788 on ClinicalTrials.gov