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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Thyroid; Nursing Caries
• Intervention / Treatment: Other: Head-of-bed elevation

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: supine 0 degree head-of-bed elevation; 0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.	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.
Experimental: 30 degree head-of-bed elevation; 30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.	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.
Experimental: 45 degree head-of-bed elevation; 45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiration rate	Number of breaths per minute. It is counted for one minute.	Every hour during four hours
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): September 30, 2013
• Study Completion (Actual): September 30, 2013

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: thyroidectomy; head-of-bed elevation; supine position; respiratory pattern; amount of drainage; peripheral oxygen saturation
• Other Study ID Numbers: 3029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No