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NCT Number: NCT01401205

The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery

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.

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Key information

Conditions

Shoulder Arthroscopic Surgery Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upper airway ultrasonographic examination

Other

upper airway ultrasonographic examination and cuff leak test

Other names: upper airway ultrasonographic examination ,, cuff leak test

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. endotracheal tube balloon cuff pressure

    Time frame: 10 min after anesthesia induction and 60 min after surgery start

    endotracheal tube balloon cuff pressure

  4. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 25, 2011
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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