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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816371
• Other study ID #: 3029
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: September 30, 2013

Study information

• Verified date: January 2019
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 30, 2013
• Est. primary completion date: September 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nursing Caries
• Surgery
• Thyroid

Intervention

Other:
• Head-of-bed elevation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration rate	Number of breaths per minute. It is counted for one minute.	Every hour during four hours
Primary	Peripheral oxygen saturation	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.	Every hour during four hours
Primary	Amount of drainage	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.	Every hour during four hours
Secondary	Dyspnea	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.	Every hour during four hours
Secondary	Hematoma formation	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.	Every hour during four hours