Airway ManagementNCT02738788
Airway Changes in Patients Undergoing Elective Surgical Procedures in the Prone and Trendelenburg Positions
An observational study of Airway Management, run by Tufts Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Intubation
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2015to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients scheduled for elective spinal surgery in the prone position or laparoscopic or surgery in the Trendelenburg position.
Who cannot join
- Patients with a preoperative MMS of 4, existing oropharyngeal pathology, or the inability to fully open their mouth, or severely limited neck mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Intraoperative Airway Changes and Their Regression to Baseline 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 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.
Read the detailed 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.
- Conditions
- Airway Management
- Being tested
- Intubation
- Keywords
- airway, airway changes, MMS, prone position, Trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-4 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start22 May 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738788
- Sponsor's protocol ID
- IRB 11705
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2016
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Intraoperative Airway Changes and Their Regression to Baseline in Patients Undergoing Elective Surgical Procedures in the Prone and Trendelenburg Positions
- ClinicalTrials.gov ID
- NCT02738788
- Acronym / sponsor ID
- IRB 11705
- Conditions
- Airway Management
- Keywords
- airway, airway changes, MMS, prone position, Trendelenburg position
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 22 May 2015 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients scheduled for elective spinal surgery in the prone position or laparoscopic or surgery in the Trendelenburg position.
Key exclusion criteria (1 listed)
- Patients with a preoperative MMS of 4, existing oropharyngeal pathology, or the inability to fully open their mouth, or severely limited neck mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntubationThe 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. | Other | – |
Primary outcome
Changes in MMS after surgery
Time frame: 1-4 hours 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in MMS after surgery (time frame: 1-4 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.