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Completed

NCT Number: NCT03816371

The Effects of Different Degrees of Head-of-bed Elevation

The patient's position is important for ensuring patient comfort and preventing complications after thyroidectomy. This study was carried out to determine the effects of different degrees of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and to provide suggestions for evidence-based clinical practice.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or malignant tumors, multinodular goiter and Graves disease. However, because of the rich vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the post anesthesia care unit following thyroidectomy to prevent hematoma formation on the incision site by facilitating venous return from the head and neck. The mentioned guideline does not offer any recommendations regarding the position that should be given to the patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the effects of different degrees of head-of-bed elevation on respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The eligible participants were those

  • who were not using anticoagulants,
  • whose coagulation tests were normal,
  • who had hemovac drains inserted during thyroidectomy,
  • who had no contraindication to positioning (e.g., heart failure, chronic obstructive pulmonary disease, dyspnea before surgery and respiratory complications in the post-anesthesia care unit),
  • who could tolerate positioning, and who volunteered to participate and signed the informed consent form

Exclusion criteria

The participants excluded from the study;

  • who were using anticoagulants,
  • whose coagulation tests were abnormal,
  • who had hemovac drains inserted during thyroidectomy,
  • hemovac drains removed in the post-anesthesia care unit following thyroidectomy,
  • who did not tolerate positioning and who refused to participate

Treatment and study plan

Head-of-bed elevation

Other

Respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation of all patients were evaluated at 1st, 2nd, 3rd, and 4th hours after positions.

Primary outcomes

  1. Respiration rate

    Time frame: Every hour during four hours

    Number of breaths per minute. It is counted for one minute.

  2. Peripheral oxygen saturation

    Time frame: Every hour during four hours

    This oxygen saturation level is used to estimate arterial blood saturation and refers to the amount of oxygenated haemoglobin in the blood. It is measured by an indirect device using non-invasive method.

  3. Amount of drainage

    Time frame: Every hour during four hours

    Drainage is the accumulation of blood in the drain suction bottle. The symptoms including red drainage and drainage more than 150 ml per hour in the suction bottle are defined as bleeding.The drain in the suction bottle is recorded hourly.

Secondary outcomes

  1. Dyspnea

    Time frame: Every hour during four hours

    Shortness of breath (dyspnea) is defined a subjective experience by individuals who complain of unpleasant or uncomfortable respiratory sensations. It is evaluated by patient expression and various instruments.

  2. Hematoma formation

    Time frame: Every hour during four hours

    Hematoma is localized swelling that is filled with blood caused by a break in the wall of a blood vessel. It is evaluated by monitoring warning signs such as progressive neck swelling, hypoxia, tachycardia, dyspnea and stridor.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

The Effects of Different Degrees of Head-of-bed Elevation on the Respiratory Pattern and Drainage Following Thyroidectomy: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2019
Registry last updated
Jan 28, 2019

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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