Clinical trial NCT03816371: The Effects of Different Degrees of Head-of-bed Elevation
Official title: The Effects of Different Degrees of Head-of-bed Elevation on the Respiratory Pattern and Drainage Following Thyroidectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Thyroid
Nursing Caries
Keywords: thyroidectomy
head-of-bed elevation
supine position
respiratory pattern
amount of drainage
peripheral oxygen saturation
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a prospective, single-center, parallel, three arm (1:1:1), randomized controlled trial at the Endocrine Surgery Clinic of a university hospital in Turkey.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiration rate
timeFrame: Every hour during four hours
measure: Peripheral oxygen saturation
timeFrame: Every hour during four hours
measure: Amount of drainage
timeFrame: Every hour during four hours
Secondary outcomes:
measure: Dyspnea
timeFrame: Every hour during four hours
measure: Hematoma formation
timeFrame: Every hour during four hours
Other outcomes:
Locations:
Study officials:
affiliation: Necmettin Erbakan University
name: Serpil Yüksel, PhD
role: PRINCIPAL_INVESTIGATOR
References: