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

NCT02738788 | Active Not Recruiting

• 1 other identifier: IRB 11705
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

airway; airway changes; MMS; prone position; Trendelenburg position

Outcome Measures

Primary Outcomes (1)

• Changes in MMS after surgery

  Based on institutional observations, we expect both prone and Trendelenburg patients to exhibit significant airway changes/increases in MMS after surgery. Additionally, we expect to find that these changes will require approximately 4 hours to fully regress, and that perioperative and intraoperative factors, such as IV fluid and steroid administration, will affect both the degree of airway changes and the time course of their regression.

  1-4 hours after surgery

Interventions

Intubation OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over the age of 18 undergoing scheduled spinal surgery in the prone position or laparoscopic or surgery in the Trendelenburg position.

You may qualify if:

• All patients scheduled for elective spinal surgery in the prone position or laparoscopic or surgery in the Trendelenburg position.

You may not qualify if:

• Patients with a preoperative MMS of 4, existing oropharyngeal pathology, or the inability to fully open their mouth, or severely limited neck mobility

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)