Postextubation StridorNCT03764904
Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery
An observational study of Postextubation Stridor, run by Ain Shams University at 1 site in Egypt.
Trial summary
literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postextubation Stridor
- What is being tested?
- Airway Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective anterior cervical surgery under general anesthesia in supine position for the first time will be enrolled in the study.
Who may be able to join
- surgeries associated with either exposure of more than three vertebral bodies,
- exposures involving the C2-C4 levels,
- blood loss exceeding 300 mL
- surgical time of more than five hours,
Who cannot join
- laryngotracheobronchial pathology,
- severe cardiorespiratory disease,
- admitted for redo-surgery
- intubated prior to operation
- Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study
literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations
- Conditions
- Postextubation Stridor
- Being tested
- Airway Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway UltrasoundRadiation
Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor
At the end of operation, laryngeal air column width [which is defined as the width of air between the vocal cords as demonstrated by US] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference [LACWD] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded.
Patient will be considered ready for extubation after performance of the cuff-leak test as [the volume of reduced cuff leak test is more than 110 ml] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more.
After transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.
Measured: First 6 hours postoperatively
Secondary outcomes (1)
Incidence of other airway complication as hematoma
Measured: Intraoperative pre-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Dec 2018
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postextubation StridorStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Khairy Elbeialy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764904
- Sponsor's protocol ID
- FMASU R 68 /2018
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03764904
- Acronym / sponsor ID
- FMASU R 68 /2018
- Conditions
- Postextubation Stridor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 5 Dec 2018 (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.
literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective anterior cervical surgery under general anesthesia in supine position for the first time will be enrolled in the study.
Key inclusion criteria (4 listed)
- surgeries associated with either exposure of more than three vertebral bodies,
- exposures involving the C2-C4 levels,
- blood loss exceeding 300 mL
- surgical time of more than five hours,
Key exclusion criteria (5 listed)
- laryngotracheobronchial pathology,
- severe cardiorespiratory disease,
- admitted for redo-surgery
- intubated prior to operation
- Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts
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 |
|---|---|---|
| Airway UltrasoundLaryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane. | Radiation | – |
Primary outcome
the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor
Time frame: First 6 hours postoperatively
At the end of operation, laryngeal air column width [which is defined as the width of air between the vocal cords as demonstrated by US] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference [LACWD] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded. Patient will be considered ready for extubation after performance of the cuff-leak test as [the volume of reduced cuff leak test is more than 110 ml] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more. After transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.
1 secondary outcome
Incidence of other airway complication as hematoma
Time frame: Intraoperative pre-extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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 Postextubation Stridor, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. 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 Egypt. 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?
Results are not available in the source record.
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?
the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor (time frame: First 6 hours postoperatively). 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 6 Dec 2018.