Airway EdemaNCT06230315
Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery
An observational study of Airway Edema, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Airway swelling and edema after cervical spine surgery(CSS) especially in prone position is the direct cause that prohibits patient from extubation. Anterior cervical discectomy and fusion causes severe peri-vertebral soft tissue swelling that was associated with increased postoperative airway complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Airway Edema
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 12 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing multilevel cervical spine surgery are recruited as study subjects. Inclusion and exclusion criteria as described above
Who may be able to join
- Adult patient age 18-70 years.
- Elective cervical spine surgeries involving in upper CSS, ≥ 2 levels, surgical duration ≥ 2 hours
- ASA class <4
Who cannot join
- RSI (rapid-sequence induction) and patients with high aspiration risk (postpartum).
- Emergency surgery
- Angioedema
- History of airway malignancy.
- Recent upper airway surgery.
- Significant recent upper airway infection or abscess.
Show all 14Show fewer
- History of radiation therapy
- Nasogastric tube in place.
- Tracheostomy in place.
- History of basal skull fracture or extensive maxillofacial fracture.
- Severe nasal septum deviation.
- Morbid obesity BMI > 40.
- Surgery involves in C1.
- History of epistaxis or bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Suny Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Direct Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery
Airway swelling and edema after cervical spine surgery(CSS) especially in prone position is the direct cause that prohibits patient from extubation. Anterior cervical discectomy and fusion causes severe peri-vertebral soft tissue swelling that was associated with increased postoperative airway complications.
Facial, lip and tongue edema in combination with the cuff leak test and risk factors are currently served as the bases on whether patient can be extubated after spine surgery. Direct visualization of the larynx and inside trachea post-operatively to assess the airway directly using flexible fiberoptic scope as well as to quantify the degree of airway edema has not been investigated.
Investigators are comparing airway before and after cervical spine surgery for any degree of narrowing in the airway using flexible fiberoptic scope. Investigators are also studying the risk factors affecting the degree of narrowing in the airway if any
Read the detailed description
Because direct visualization of the airway is the most reliable way for the diagnosing and assessing the degree of laryngeal and trachea edema or swelling, investigators sought to do a study to evaluate the degree of airway edema in adult patients undergoing for CSS using direct visualization via flexible fiberoptic and compare the results pre and post- operatively.
The primary outcome will be severity of larynx and trachea edema after cervical spine surgery.
Secondary outcome will be assessment of reliability of airway leak technique and association between face swelling and airway edema.
18 years old and above, 63 number of patient will be enrolled in the study. Patient enrolled who are under going elective cervical spine surgery.Patients involved in the study will be taken to the OR, after induction and prior to intubation asleep flexible fiberoptic scope will be inserted nasally and video record will be taken above and below the glottis, surgery will be continued as planned.
The primary analysis is to test the association of the severity of the laryngeal and tracheal edema with surgical time and number of levels involved in surgery. Investigators will also perform an exploratory analysis to examine the impact of other potential risk factor, including age, fluids and blood products transfusions, ASA( American Society of Anesthesiology) physical status, facial swelling and cuff leak After conclusion of surgery, and when patients are ready for extubation. Quantitative cuff leak will be done, flexible fiber optic scope will be placed through the endotracheal tube, and at the same time of extubation fiber optic scope will be pulled slowly with the endotracheal tube while recording video until we reach a point that approximate same point video was taken prior to intubation, patients who will remain intubated nasal scope will be placed and video will be taken above the glottis with the endotracheal tube in place, another video will be taken for the airway from inside the endotracheal tube.
Study will be aborted if significant resistance during placement of the fiberoptic scope, nasal bleeding happens or hypoxemia requiring ventilation.
Pictures will be saved on USB device and will be assigned a random code that is non-leading to which videos were taken before surgery and which were taken after surgery. Recording prior to intubation will be done as we are withdrawing the scope out, so the motion will be similar to the motion in the video recorded with extubation, hoping that this will be less leading to the blinded ENT surgeon to which was taken before and which after. Patient that will be kept intubated are not blinded.
Pictures will be then shown to ENT surgeon to assess and compare preoperative and postoperative outcome.
Severity of the laryngeal tracheal edema is classified into mild, moderate, and severe. According to the reduction of the cross-section of the trachea lumen, Mild edema is defined as reduction <30%, Moderate < 50%, severe >50% (8).
ENT surgeon will grade the degree of narrowing in the trachea to:
- No edema to < 30%
- 31%-50%
- > 50%.
And above the trachea into
- none.
- mild.
- severe.
- Conditions
- Airway Edema
- Keywords
- leak test, cervical spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine surgery patients | Patients undergoing multilevel cervical spine surgery at Upstate University hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of airway swelling - subglottic and supraglottic
Surgical time and number of levels involved in surgery as factors affecting degree of airway swelling.
Measured: 24 hours
Secondary outcomes (1)
Degree of airway swelling - subglottic and supraglottic
Examine the impact of other potential risk factors including age, fluids and blood products transfusions, ASA status, facial swelling and cuff leak.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startNov 2016
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway EdemaStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luay Nubani, MBCHB, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230315
- Sponsor's protocol ID
- 905477-11
- Status last verified
- Jan 2024
- First submitted
- 5 Sep 2018
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT06230315
- Acronym / sponsor ID
- 905477-11
- Conditions
- Airway Edema
- Keywords
- leak test, cervical spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 30 Jan 2024 (actual)
- 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.
Airway swelling and edema after cervical spine surgery(CSS) especially in prone position is the direct cause that prohibits patient from extubation. Anterior cervical discectomy and fusion causes severe peri-vertebral soft tissue swelling that was associated with increased postoperative airway complications.
Facial, lip and tongue edema in combination with the cuff leak test and risk factors are currently served as the bases on whether patient can be extubated after spine surgery. Direct visualization of the larynx and inside trachea post-operatively to assess the airway directly using flexible fiberoptic scope as well as to quantify the degree of airway edema has not been investigated.
Investigators are comparing airway before and after cervical spine surgery for any degree of narrowing in the airway using flexible fiberoptic scope. Investigators are also studying the risk factors affecting the degree of narrowing in the airway if any
Detailed description
Because direct visualization of the airway is the most reliable way for the diagnosing and assessing the degree of laryngeal and trachea edema or swelling, investigators sought to do a study to evaluate the degree of airway edema in adult patients undergoing for CSS using direct visualization via flexible fiberoptic and compare the results pre and post- operatively.
The primary outcome will be severity of larynx and trachea edema after cervical spine surgery.
Secondary outcome will be assessment of reliability of airway leak technique and association between face swelling and airway edema.
18 years old and above, 63 number of patient will be enrolled in the study. Patient enrolled who are under going elective cervical spine surgery.Patients involved in the study will be taken to the OR, after induction and prior to intubation asleep flexible fiberoptic scope will be inserted nasally and video record will be taken above and below the glottis, surgery will be continued as planned.
The primary analysis is to test the association of the severity of the laryngeal and tracheal edema with surgical time and number of levels involved in surgery. Investigators will also perform an exploratory analysis to examine the impact of other potential risk factor, including age, fluids and blood products transfusions, ASA( American Society of Anesthesiology) physical status, facial swelling and cuff leak After conclusion of surgery, and when patients are ready for extubation. Quantitative cuff leak will be done, flexible fiber optic scope will be placed through the endotracheal tube, and at the same time of extubation fiber optic scope will be pulled slowly with the endotracheal tube while recording video until we reach a point that approximate same point video was taken prior to intubation, patients who will remain intubated nasal scope will be placed and video will be taken above the glottis with the endotracheal tube in place, another video will be taken for the airway from inside the endotracheal tube.
Study will be aborted if significant resistance during placement of the fiberoptic scope, nasal bleeding happens or hypoxemia requiring ventilation.
Pictures will be saved on USB device and will be assigned a random code that is non-leading to which videos were taken before surgery and which were taken after surgery. Recording prior to intubation will be done as we are withdrawing the scope out, so the motion will be similar to the motion in the video recorded with extubation, hoping that this will be less leading to the blinded ENT surgeon to which was taken before and which after. Patient that will be kept intubated are not blinded.
Pictures will be then shown to ENT surgeon to assess and compare preoperative and postoperative outcome.
Severity of the laryngeal tracheal edema is classified into mild, moderate, and severe. According to the reduction of the cross-section of the trachea lumen, Mild edema is defined as reduction <30%, Moderate < 50%, severe >50% (8).
ENT surgeon will grade the degree of narrowing in the trachea to:
- No edema to < 30%
- 31%-50%
- > 50%.
And above the trachea into
- none.
- mild.
- severe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spine surgery patients | – | –Patients undergoing multilevel cervical spine surgery at Upstate University hospital |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing multilevel cervical spine surgery are recruited as study subjects. Inclusion and exclusion criteria as described above
Key inclusion criteria (3 listed)
- Adult patient age 18-70 years.
- Elective cervical spine surgeries involving in upper CSS, ≥ 2 levels, surgical duration ≥ 2 hours
- ASA class <4
Key exclusion criteria (14 listed)
- RSI (rapid-sequence induction) and patients with high aspiration risk (postpartum).
- Emergency surgery
- Angioedema
- History of airway malignancy.
- Recent upper airway surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of airway swelling - subglottic and supraglottic
Time frame: 24 hours
Surgical time and number of levels involved in surgery as factors affecting degree of airway swelling.
1 secondary outcome
Degree of airway swelling - subglottic and supraglottic
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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.
Luay Nubani, MBCHB principal investigator
State University of New York - Upstate Medical University
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 Edema, run by State University of New York - Upstate Medical University 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 30 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of airway swelling - subglottic and supraglottic (time frame: 24 hours). 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 30 Jan 2024.