The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery

December 24, 2013 updated by: Sujoo Choi, Samsung Medical Center

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
shoulder arthroscopic surgery group
the patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair
upper airway ultrasonographic examination and cuff leak test
Other Names:
  • upper airway ultrasonographic examination ,
  • cuff leak test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 min before anesthesia induction
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)
20 min after end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depth of skin to airway anterior border
Time Frame: 10 min before anesthesia induction and 20 min after the surgery
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
depth of skin to pleura
Time Frame: 10 min before anesthesia induction and 20 min after the end of surgery
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
endotracheal tube balloon cuff pressure
Time Frame: 10 min after anesthesia induction and 60 min after surgery start
endotracheal tube balloon cuff pressure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Soo Joo Choi, M.D.,Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-06-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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