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

NCT ID: NCT03816371

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Surgery Thyroid Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Group allocation was concealed using individual sealed opaque envelopes that were numbered in sequential order. As individuals were enrolled in the study, the next envelope in the sequence was extracted and the participant was assigned to the groups accordingly. All the researchers except for the clinical nurse who positioned the patients according to randomization list and patients were blinded from group assignment.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Head-of-bed elevation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Head-of-bed elevation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Head-of-bed elevation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Serpil Yüksel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serpil Yüksel, PhD

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Other Identifiers

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3029

Identifier Type: -

Identifier Source: org_study_id

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