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NCT02738788 · ClinicalTrials.gov registry record

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

A clinical trial of Airway Management, sponsored by Tufts Medical Center.

Active
Registry status
180
Enrollment target
1
Study location

NCT02738788: Active study of Airway Management, sponsored by Tufts Medical Center.

NCT02738788 is a study of Airway Management that is active but no longer recruiting, run by Tufts Medical Center. The registered enrollment target is 180 participants, below the 3,795-participant average among 4 other Airway Management trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02738788, a study of Airway Management, is active but no longer recruiting, sponsored by Tufts Medical Center.

ACTIVE NOT RECRUITING
Registry status
180 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Interventions

  • OTHER Intubation

Study Locations (1)

Massachusetts

  • Tufts Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2015-05
Est. Completion 2026-07-31
Tufts Medical Center

169 total trials

What the registry record for NCT02738788 still lists

NCT02738788 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 3,795-participant average among 4 other Airway Management trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Airway Management appearing as the primary indexed condition, and to 1 intervention - of which Intubation is the first listed.

NCT02738788 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02738788 about?

NCT02738788 is a clinical study titled "Airway Changes in Patients Undergoing Elective Surgical Procedures in the Prone and Trendelenburg Positions". 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...

What is the current status of trial NCT02738788?

This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 2015-05. Estimated completion is 2026-07-31.

What conditions does trial NCT02738788 study?

This clinical trial studies the following conditions: Airway Management.

What interventions are being tested in trial NCT02738788?

The interventions under investigation include: Intubation (OTHER).

Who is sponsoring clinical trial NCT02738788?

This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02738788 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02738788, the US trial registry maintained by the National Library of Medicine. NCT02738788 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.