The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery

Shoulder Arthroscopic Surgery Clinical Trial

Official title:

The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401205
• Other study ID #: 2011-06-028
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: December 24, 2013
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shoulder Arthroscopic Surgery

Intervention

Other:
• upper airway ultrasonographic examination
upper airway ultrasonographic examination and cuff leak test

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway transverse diameter	airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)	10 min before anesthesia induction	No
Primary	Airway transverse diameter	airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)	20 min after end of surgery	No
Secondary	depth of skin to airway anterior border	depth of skin to airway anterior border measured at three levels: vocal cord, subglottis, trachea level	10 min before anesthesia induction and 20 min after the surgery	No
Secondary	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	10 min before anesthesia induction and 20 min after the end of surgery	No
Secondary	endotracheal tube balloon cuff pressure	endotracheal tube balloon cuff pressure	10 min after anesthesia induction and 60 min after surgery start	No
Secondary	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.	10 min after anesthesia induction and 60 min after surgery start	No