SurgeryNCT03816371
The Effects of Different Degrees of Head-of-bed Elevation
A study testing Head-of-bed elevation in people with Surgery and Thyroid, run by Necmettin Erbakan University.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Thyroid, Nursing Caries
- What is being tested?
- Head-of-bed elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 30 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Thyroid, Nursing Caries
- Being tested
- Head-of-bed elevation
- Keywords
- thyroidectomy, head-of-bed elevation, supine position, respiratory pattern, amount of drainage, peripheral oxygen saturation
- Medical subject headings
- Thyroid Diseases, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-of-bed elevationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Head-of-bed elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration rate
Number of breaths per minute. It is counted for one minute.
Measured: 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.
Measured: 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.
Measured: Every hour during four hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: Every hour during four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 May 2013
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Yüksel, Necmettin Erbakan University
- Investigators
- Serpil Yüksel, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816371
- Sponsor's protocol ID
- 3029
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Degrees of Head-of-bed Elevation on the Respiratory Pattern and Drainage Following Thyroidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03816371
- Acronym / sponsor ID
- 3029
- Conditions
- Surgery, Thyroid, Nursing Caries
- Keywords
- thyroidectomy, head-of-bed elevation, supine position, respiratory pattern, amount of drainage, peripheral oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| supine 0 degree head-of-bed elevation | Active comparator | Other: Head-of-bed elevation0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy. |
| 30 degree head-of-bed elevation | Experimental | Other: Head-of-bed elevation30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy. |
| 45 degree head-of-bed elevation | Experimental | Other: Head-of-bed elevation45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-of-bed elevationRespiratory 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. | Other | 30 degree head-of-bed elevation, 45 degree head-of-bed elevation, supine 0 degree head-of-bed elevation |
Primary outcome
Respiration rate
Time frame: Every hour during four hours
Number of breaths per minute. It is counted for one minute.
Peripheral oxygen saturation
Time frame: Every hour during four hours
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.
Amount of drainage
Time frame: Every hour during four hours
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.
2 secondary outcomes
Dyspnea
Time frame: Every hour during four hours
Hematoma formation
Time frame: Every hour during four hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serpil Yüksel, PhD principal investigator
Necmettin Erbakan University
Questions about this trial
What is this clinical trial studying?
A study testing Head-of-bed elevation in people with Surgery and Thyroid, run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration rate (time frame: Every hour during four hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.