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

Not Applicable

Completed

• Conditions: Thyroid; Surgery; Nursing Caries
• Interventions: Other: Head-of-bed elevation

• Registration Number: NCT03816371
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2013-09-30
• Study Completion: 2013-09-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-24
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine 0 degree head-of-bed elevation	Head-of-bed elevation	0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
30 degree head-of-bed elevation	Head-of-bed elevation	30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
45 degree head-of-bed elevation	Head-of-bed elevation	45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.

Primary Outcome Measures

Name	Time	Method
Respiration rate	Every hour during four hours	Number of breaths per minute. It is counted for one minute.
Peripheral oxygen saturation	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.
Amount of drainage	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 Outcome Measures

Name	Time	Method
Dyspnea	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.
Hematoma formation	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.