Clinical trial NCT01401205: The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery
Official title: The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Arthroscopic Surgery
Keywords: shoulder arthroscopic surgery
dyspnea
airway diameter
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

Exclusion Criteria:

* patients with airway anomaly
* patients with anticipated difficult airway
* patients with hemodynamic unstability
* patients with severe cardiopulmonary disease

Primary outcomes:
measure: Airway transverse diameter
timeFrame: 10 min before anesthesia induction
measure: Airway transverse diameter
timeFrame: 20 min after end of surgery
Secondary outcomes:
measure: depth of skin to airway anterior border
timeFrame: 10 min before anesthesia induction and 20 min after the surgery
measure: depth of skin to pleura
timeFrame: 10 min before anesthesia induction and 20 min after the end of surgery
measure: endotracheal tube balloon cuff pressure
timeFrame: 10 min after anesthesia induction and 60 min after surgery start
measure: percent cuff leak
timeFrame: 10 min after anesthesia induction and 60 min after surgery start
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Soo Joo Choi, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: