Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02738788
Other study ID # IRB 11705
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2015
Est. completion date July 31, 2025

Study information

Verified date February 2024
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Background: One of the primary methods to assess airway dimension changes is the Modified Mallampati Score (MMS). MMS has been a valuable tool in assessing difficulty of intubation in previous studies as it is a simple, reproducible, and reliable preoperative and preanesthetic assessment of oral volume. MMS is evaluated by asking the patient to open their mouth and protrude their tongue without phonation. A score on a scale of 1-4 is assigned based on identifiable intraoral anatomic structures. MMS scores of 3 and 4 are strongly associated with difficult laryngoscopy and intubation. Extensive observational research in the obstetric population has demonstrated that airway changes, including increasing MMS and decreasing oropharyngeal volume, occur during labor. It has been found that 63% of parturients experienced an increase in MMS over the course of their labor, with the fraction of patients scoring 3 or 4 peaking at 51.7%, compared with only 10.3% early in labor. Notably, of those patients that reached a class 4, 21% remained at that classification 48 hours postpartum. It has been found that 18% of patients whose airway class worsened during labor had not returned to their prelabor class 36-48 hours after delivery. These obstetric findings have prompted a limited number of studies investigating airway changes in patients undergoing surgical procedures. This study will focus on surgeries in the prone and Trendelenburg positions, as they would intuitively predispose patients to edema and fluid retention in the head and neck. MMS increased in 78% of patients, with 29% increasing by two or more classes in patients undergoing lumbar spine surgery in the prone position. Furthermore, although laparoscopic surgery has been shown to increase lung and chest wall mechanical impedance, which leads to increases in abdominal and intrathoracic pressure, as well as an increase in central venous pressure with subsequent increases in intraocular pressure, no studies have been performed to specifically track resultant airway changes. Lastly, to investigators' knowledge no studies have investigated the postoperative resolution of airway changes after either type of procedure. Rationale: There is evidence, both investigational and anecdotal, that airway changes may occur during certain surgeries or procedures, and that patient positioning may play a large role in precipitating them. However, research on this phenomenon in the surgical population, unlike the obstetric population, is sparse. Similarly, investigations into the time required for airway changes to regress back to baseline has been included in a number of obstetric airway studies, but not in any surgical ones. Lastly, it has been suggested that other surgical factors, such as fluid balance or procedure duration, may alter the degree of airway changes, but results from the few recent studies on the topic have been unclear. Thus, this study seeks to further investigate the influence of prone and Trendelenburg positioning, as well as surgical variables, on perioperative airway changes, and quantify the time required for patients' airways to return to their preoperative state. Based on clinical observation, the primary hypothesis is that there will be a significant difference between mean scoring class change between 2 study groups from preoperative baseline to initial postoperative assessment. Investigators hypothesize that T-burg surgery patients will have a mean change of 2 classes compared to a mean change of only one class for prone spine surgery patients. The secondary hypothesis is that airway changes occurring in patients undergoing prone procedures will resolve significantly sooner than (3 - 4 hours) than those of patients undergoing Trendelenburg surgeries (> 4 hours). Thirdly investigators will investigate the effects of demographic, physiological, and surgical & anesthetic variables on postoperative MMS changes and their resolution.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date July 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients scheduled for elective spinal surgery in the prone position or laparoscopic or surgery in the Trendelenburg position. Exclusion Criteria: - Patients with a preoperative MMS of 4, existing oropharyngeal pathology, or the inability to fully open their mouth, or severely limited neck mobility

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03908411 - The Effect of Paratracheal Pressure on the Glottic View N/A
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A