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

NCT03816371 | Completed

• 1 other identifier: 3029
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery; Thyroid; Nursing Caries

Keywords

thyroidectomy; head-of-bed elevation; supine position; respiratory pattern; amount of drainage; peripheral oxygen saturation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Dyspnea

  Every hour during four hours

• Hematoma formation

  Every hour during four hours

Study Arms (3)

supine 0 degree head-of-bed elevation

ACTIVE COMPARATOR

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

30 degree head-of-bed elevation

EXPERIMENTAL

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

45 degree head-of-bed elevation

EXPERIMENTAL

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

Interventions

Head-of-bed elevation 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; 45 degree head-of-bed elevation; supine 0 degree head-of-bed elevation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

MeSH Terms

Conditions

Thyroid Diseases; Deception

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Serpil Yüksel, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: May 1, 2013
• Primary Completion: September 30, 2013
• Study Completion: September 30, 2013
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share