Shoulder Arthroscopic SurgeryNCT01401205
The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery
An observational study of Shoulder Arthroscopic Surgery, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Shoulder Arthroscopic Surgery
- What is being tested?
- upper airway ultrasonographic examination
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Dec 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)
Who may be able to join
- patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)
Who cannot join
- patients with airway anomaly
- patients with anticipated difficult airway
- patients with hemodynamic unstability
- patients with severe cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography
The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.
Read the detailed description
During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications.
An endotracheal tube is the most reliable method of securing the airway from airway obstruction during a shoulder arthroscopy surgery. However, since the airway may become obstructed after extubation, airway patency should be verified before extubation. Direct visualization of the larynx or trachea using laryngoscopy or bronchoscopy is difficult due to the presence of the tracheal tube. A cuff leak around the tracheal tube in a cuff-deflated condition is suggested to be a predictor of successful extubation. However, its reliability has been questioned in adult patients. A cuff leak could be affected by paratracheal pressure, which is thought to be elevated during shoulder arthroscopy. In a recent study, it was shown that laryngeal ultrasound can be a reliable, non-invasive method for the evaluation of laryngeal morphology or predicting post-extubation stridor.
The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.
- Conditions
- Shoulder Arthroscopic Surgery
- Being tested
- upper airway ultrasonographic examination
- Keywords
- shoulder arthroscopic surgery, dyspnea, airway diameter
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper airway ultrasonographic examinationOther
Also called upper airway ultrasonographic examination ,, cuff leak test
upper airway ultrasonographic examination and cuff leak test
| Study group | Role | What they receive |
|---|---|---|
| shoulder arthroscopic surgery group | the patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair Receives: Other: upper airway ultrasonographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway transverse diameter
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
Measured: 10 min before anesthesia induction
Airway transverse diameter
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
Measured: 20 min after end of surgery
Secondary outcomes (4)
depth of skin to airway anterior border
depth of skin to airway anterior border measured at three levels: vocal cord, subglottis, trachea level
Measured: 10 min before anesthesia induction and 20 min after the surgery
depth of skin to pleura
bilateral depth of skin to pleura at first and third intercostal space on the midclavicualr line measuread on the ultrasonographic image
Measured: 10 min before anesthesia induction and 20 min after the end of surgery
endotracheal tube balloon cuff pressure
endotracheal tube balloon cuff pressure
Measured: 10 min after anesthesia induction and 60 min after surgery start
percent cuff leak
The difference in the actual exhaled volume between the averages of pre- and post-cuff deflation was calculated. This number was divided by the tidal volume before cuff deflation and multiplied by 100. The resulting number was recorded as the percent cuff leak.
Measured: 10 min after anesthesia induction and 60 min after surgery start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthroscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujoo Choi, Samsung Medical Center
- Investigators
- Soo Joo Choi, M.D.,Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401205
- Sponsor's protocol ID
- 2011-06-028
- Status last verified
- Dec 2013
- First submitted
- 21 Jul 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography
- ClinicalTrials.gov ID
- NCT01401205
- Acronym / sponsor ID
- 2011-06-028
- Conditions
- Shoulder Arthroscopic Surgery
- Keywords
- shoulder arthroscopic surgery, dyspnea, airway diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jul 2011 (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 investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.
Detailed description
During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications.
An endotracheal tube is the most reliable method of securing the airway from airway obstruction during a shoulder arthroscopy surgery. However, since the airway may become obstructed after extubation, airway patency should be verified before extubation. Direct visualization of the larynx or trachea using laryngoscopy or bronchoscopy is difficult due to the presence of the tracheal tube. A cuff leak around the tracheal tube in a cuff-deflated condition is suggested to be a predictor of successful extubation. However, its reliability has been questioned in adult patients. A cuff leak could be affected by paratracheal pressure, which is thought to be elevated during shoulder arthroscopy. In a recent study, it was shown that laryngeal ultrasound can be a reliable, non-invasive method for the evaluation of laryngeal morphology or predicting post-extubation stridor.
The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder arthroscopic surgery group | – | Other: upper airway ultrasonographic examinationthe patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)
Key inclusion criteria (1 listed)
- patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)
Key exclusion criteria (4 listed)
- patients with airway anomaly
- patients with anticipated difficult airway
- patients with hemodynamic unstability
- patients with severe cardiopulmonary disease
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 |
|---|---|---|
| upper airway ultrasonographic examinationAlso: upper airway ultrasonographic examination ,, cuff leak testupper airway ultrasonographic examination and cuff leak test | Other | shoulder arthroscopic surgery group |
Primary outcome
Airway transverse diameter
Time frame: 10 min before anesthesia induction
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
Airway transverse diameter
Time frame: 20 min after end of surgery
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
4 secondary outcomes
depth of skin to airway anterior border
Time frame: 10 min before anesthesia induction and 20 min after the surgery
depth of skin to pleura
Time frame: 10 min before anesthesia induction and 20 min after the end of surgery
endotracheal tube balloon cuff pressure
Time frame: 10 min after anesthesia induction and 60 min after surgery start
percent cuff leak
Time frame: 10 min after anesthesia induction and 60 min after surgery start
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 25 Dec 2013.
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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.
Soo Joo Choi, M.D.,Ph.D. principal investigator
Samsung Medical Center
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 Shoulder Arthroscopic Surgery, run by Samsung Medical Center at 1 site in South Korea.
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 4 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 25 Dec 2013. 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 South Korea. 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?
Airway transverse diameter (time frame: 10 min before anesthesia induction). The study lists 2 primary outcomes in all. 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 25 Dec 2013.