RhinoplastyNCT05695794
The Effect of Different Bed Head Heights on Patients After Rhinoplasty
A study testing the group with a bed head height of 45 degrees and the group with a bed head height of 30 degrees in people with Rhinoplasty, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to evaluate the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients after rhinoplasty surgery on periorbital edema, periorbital ecchymosis, respiratory function and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- the group with a bed head height of 45 degrees and the group with a bed head height of 30 degrees
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2022to Jun 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participating in the research voluntarily
- Patients over the age of 18
- Patients who have undergone rhinoplasty for aesthetic purposes
- Can speak Turkish
- Patients who do not have a mental disability that may interfere with communication
- Patients who had rhinoplasty with open technique
- Patients without diagnosed respiratory and sleep disorders
Who cannot join
- Patients who did not agree to participate in the study
- Patients under the age of 18
- Patients who underwent rhinoplasty surgery due to trauma
- Patients with mental disabilities who interfere with communication
- Patients who cannot adapt to bed height
- Patients who had rhinoplasty surgery with the closed technique
- Patients with diagnosed respiratory and sleep disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Ataturk State Hospital
Zonguldak, 67030
About this study
Official title: Evaluation of the Effect of Different Bed Head Heights After Rhinoplasty on Edema, Ecchymosis, Respiratory Function and Sleep Quality
This study will be conducted to evaluate the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients after rhinoplasty surgery on periorbital edema, periorbital ecchymosis, respiratory function and sleep quality.
Read the detailed description
The nose is morphologically a functional and aesthetic organ. These two concepts are inseparable and interact with each other. The nose is one of the structures most exposed to trauma, especially on the face. Rhinoplasty is one of the most common operations performed by plastic surgeons for functional correction or cosmetic purposes. When we examine the history of nose surgeries, we see that nose surgeries begin with reconstruction. Reduction rhinoplasty emerged later and forms the basis of today's rhinoplasty. The treatment of nasal trauma was first mentioned in the Edwin Smith Surgical Papyrus in 3000 BC (BC). In these papyri, 48 patients were reported to have been treated surgically. In the 5th century BC, Hippocrates made detailed patient analysis in his work named "Mochlicon" and classified nasal injuries from simple fracture to complicated. He discussed the reduction of nasal bones and their treatment with poultice. Most historians reported that nasal reconstruction was first mentioned in Sanskrit writings in Ancient India. In these writings, it was reported that the noses of Hindu women were cut as punishment. B.C. In the 6th century; Sushruta performed the reconstruction of the nose using his own instruments. He performed tissue transfer from forehead and cheek to nose. He called it the Indian Method. Sushruta mentioned the nasal reconstruction methods he developed in his book Samhita. 1st century There are articles describing the nose reconstruction in the book called De Medicina, which was written in Rome. VII. In the sculpture of the Byzantine Emperor in the 16th century, it is depicted that there is a scar on his forehead. It was accepted that this was a sign of nasal reconstruction. With the Muslim conquest of India, the nose reconstruction techniques applied in India started to be used in Muslim countries as well. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XV. In the 19th century, the Italian surgeon Branca introduced the Indian Method in nose surgery to Europe. Branca's son Antonio, on the other hand, developed a new method in nose surgery and named it the "Italian Method". Nose surgeries have been performed with open technique for centuries. It was Jacques Joseph who coined the term "open rhinoplasty" for the first time, which he would later adopt in Millard and Gillies. Joseph is the scientist who introduced techniques such as nasal dorsum reconstruction with bone grafting and cartilage suturing to rhinoplasty. The first to describe the closed approach in rhinoplasty was John O Roe (1887), an American surgeon. Later, Weir presented the closed technique in 1892 and the German J. Joseph in 1898. In the closed technique, incisions are made through the nose, and in the open technique, a very small incision of approximately 2 millimeters in length is made in the columella of the nose (the part visible from the outside of the middle support) in addition to the incisions made through the nose. If the nose wings need to be narrowed; Additional incisions of approximately 5-6 millimeters can also be made so that they remain in the fold at the base of the nose wings. As with all surgical interventions, the comfort of the patient is important after rhinoplasty. Factors affecting the comfort of the patient in the early period after rhinoplasty; nausea, vomiting, bleeding, periorbital edema, periorbital ecchymosis, nasal airway obstruction and pain. Among these, the factors that most affect the comfort of the patient are; pain, periorbital edema and periorbital ecchymosis. Occurrence of periorbital edema and periorbital ecchymosis; Even if it is a natural result of the procedure, it is an undesirable result for patients who undergo this procedure with aesthetic demands. Postoperative periorbital edema and periorbital ecchymosis cause a delay in patients' return to daily life and adversely affect their social lives. Depending on the degree of periorbital edema, visual difficulties may also be experienced in the early postoperative period. Periorbital ecchymosis occurs by extravasation from damaged vessels and can be positioned by the effect of gravity. This may cause color change in the operation area and delays in returning to the patient's normal social life. Various agents such as corticosteroids, arnica, lidocaine, adrenaline combination and Melilotus extract and cold application methods for different durations have been used to reduce periorbital edema and periorbital ecchymosis after rhinoplasty. In line with these scanned literatures, it was observed that studies on bed head height after rhinoplasty were limited, and it was observed that there was no common decision on bed head heights given to patients in practice.For these reasons, it was decided to examine the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients on periorbital edema, periorbital ecchymosis and respiratory functions.
- Conditions
- Rhinoplasty
- Being tested
- the group with a bed head height of 45 degrees, the group with a bed head height of 30 degrees
- Keywords
- Rhinoplasty, Edema, Ecchymosis, Respiratory Function Tests, Sleep Quality
- Medical subject headings
- Edema, Ecchymosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the group with a bed head height of 45 degreesOther
Also called Nursing care intervention for positioning appropriately after surgery
Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving a 45 degree head height to 30 patients determined by Randomizer.org.
the group with a bed head height of 30 degreesOther
Also called Nursing care intervention for positioning appropriately after surgery
Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving 30 degrees of bed head height to 30 patients determined by Randomizer.org.
| Study group | Role | What they receive |
|---|---|---|
| the group with a bed head height of 45 degrees | Other | The bed head height of the patients in this group will be adjusted to 45 degrees. This group was determined as the control group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted. Receives: Other: the group with a bed head height of 45 degrees |
| the group with a bed head height of 30 degrees | Experimental | The bed head height of the patients in this group will be adjusted to 30 degrees. This group was determined as the experimental group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted. Receives: Other: the group with a bed head height of 30 degrees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periorbital edema score
This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema
- point: Mild periorbital edema
- points: Periorbital edema enlarged towards the iris layer of the eye
- points: Periorbital edema covering the iris
- points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Measured: 1 hour after surgery
Periorbital edema score
This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema
- point: Mild periorbital edema
- points: Periorbital edema enlarged towards the iris layer of the eye
- points: Periorbital edema covering the iris
- points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Measured: 4 hours after surgery
Periorbital edema score
This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema
- point: Mild periorbital edema
- points: Periorbital edema enlarged towards the iris layer of the eye
- points: Periorbital edema covering the iris
- points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Measured: 24th hour after surgery
Right and left periorbital ecchymosis score
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid.
3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
Measured: 1 hour after surgery
Right and left periorbital ecchymosis score
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid.
3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
Measured: 4 hours after surgery
Right and left periorbital ecchymosis score
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid.
3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
Measured: 24th hour after surgery
Secondary outcomes (6)
Monitoring the change in fever
Vital signs (fever) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in systolic blood pressure
Vital signs (systolic blood pressure) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in diastolic blood pressure
Vital signs (diastolic blood pressure) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in pulse
Vital signs (pulse) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in oxygen saturation
The change in the oxygen saturation values of the patients will be followed by noninvasive peripheral pulse oximetry.The patient's oxygen saturation value will be monitored every 4 hours, unlike the routine treatment and follow-up hours of the hospital. The saturation value will not be measured while the patient is asleep. A questionnaire will be applied to the patient to evaluate the patient's breathing in the morning after the surgery.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Richard's Campbell Sleep Scale
It is a scale consisting of 6 items. These 6 items evaluate the depth of night sleep, the time to fall asleep, the frequency of waking up, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Evaluation of the scale, on the other hand, is that the score between 0-25 is "very bad sleep", and the score between "76-100" is "very good sleep". As the score of the scale increases, the sleep quality of the patients also increases.
Measured: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start8 Dec 2022
- Primary completion21 Mar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental group and control group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şevval Polat, Bartın Unıversity
- Investigators
- Şevval Polat, Principal investigator, Uzunmehmet chest and occupational diseases hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695794
- Sponsor's protocol ID
- BartınU-SBF-SP-01
- Status last verified
- Jan 2023
- First submitted
- 22 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Bed Head Heights After Rhinoplasty on Edema, Ecchymosis, Respiratory Function and Sleep Quality
- ClinicalTrials.gov ID
- NCT05695794
- Acronym / sponsor ID
- BartınU-SBF-SP-01
- Conditions
- Rhinoplasty
- Keywords
- Rhinoplasty, Edema, Ecchymosis, Respiratory Function Tests, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 21 Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jan 2023 (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.
This study will be conducted to evaluate the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients after rhinoplasty surgery on periorbital edema, periorbital ecchymosis, respiratory function and sleep quality.
Detailed description
The nose is morphologically a functional and aesthetic organ. These two concepts are inseparable and interact with each other. The nose is one of the structures most exposed to trauma, especially on the face. Rhinoplasty is one of the most common operations performed by plastic surgeons for functional correction or cosmetic purposes. When we examine the history of nose surgeries, we see that nose surgeries begin with reconstruction. Reduction rhinoplasty emerged later and forms the basis of today's rhinoplasty. The treatment of nasal trauma was first mentioned in the Edwin Smith Surgical Papyrus in 3000 BC (BC). In these papyri, 48 patients were reported to have been treated surgically. In the 5th century BC, Hippocrates made detailed patient analysis in his work named "Mochlicon" and classified nasal injuries from simple fracture to complicated. He discussed the reduction of nasal bones and their treatment with poultice. Most historians reported that nasal reconstruction was first mentioned in Sanskrit writings in Ancient India. In these writings, it was reported that the noses of Hindu women were cut as punishment. B.C. In the 6th century; Sushruta performed the reconstruction of the nose using his own instruments. He performed tissue transfer from forehead and cheek to nose. He called it the Indian Method. Sushruta mentioned the nasal reconstruction methods he developed in his book Samhita. 1st century There are articles describing the nose reconstruction in the book called De Medicina, which was written in Rome. VII. In the sculpture of the Byzantine Emperor in the 16th century, it is depicted that there is a scar on his forehead. It was accepted that this was a sign of nasal reconstruction. With the Muslim conquest of India, the nose reconstruction techniques applied in India started to be used in Muslim countries as well. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XV. In the 19th century, the Italian surgeon Branca introduced the Indian Method in nose surgery to Europe. Branca's son Antonio, on the other hand, developed a new method in nose surgery and named it the "Italian Method". Nose surgeries have been performed with open technique for centuries. It was Jacques Joseph who coined the term "open rhinoplasty" for the first time, which he would later adopt in Millard and Gillies. Joseph is the scientist who introduced techniques such as nasal dorsum reconstruction with bone grafting and cartilage suturing to rhinoplasty. The first to describe the closed approach in rhinoplasty was John O Roe (1887), an American surgeon. Later, Weir presented the closed technique in 1892 and the German J. Joseph in 1898. In the closed technique, incisions are made through the nose, and in the open technique, a very small incision of approximately 2 millimeters in length is made in the columella of the nose (the part visible from the outside of the middle support) in addition to the incisions made through the nose. If the nose wings need to be narrowed; Additional incisions of approximately 5-6 millimeters can also be made so that they remain in the fold at the base of the nose wings. As with all surgical interventions, the comfort of the patient is important after rhinoplasty. Factors affecting the comfort of the patient in the early period after rhinoplasty; nausea, vomiting, bleeding, periorbital edema, periorbital ecchymosis, nasal airway obstruction and pain. Among these, the factors that most affect the comfort of the patient are; pain, periorbital edema and periorbital ecchymosis. Occurrence of periorbital edema and periorbital ecchymosis; Even if it is a natural result of the procedure, it is an undesirable result for patients who undergo this procedure with aesthetic demands. Postoperative periorbital edema and periorbital ecchymosis cause a delay in patients' return to daily life and adversely affect their social lives. Depending on the degree of periorbital edema, visual difficulties may also be experienced in the early postoperative period. Periorbital ecchymosis occurs by extravasation from damaged vessels and can be positioned by the effect of gravity. This may cause color change in the operation area and delays in returning to the patient's normal social life. Various agents such as corticosteroids, arnica, lidocaine, adrenaline combination and Melilotus extract and cold application methods for different durations have been used to reduce periorbital edema and periorbital ecchymosis after rhinoplasty. In line with these scanned literatures, it was observed that studies on bed head height after rhinoplasty were limited, and it was observed that there was no common decision on bed head heights given to patients in practice.For these reasons, it was decided to examine the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients on periorbital edema, periorbital ecchymosis and respiratory functions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental group and control group
| Arm | Type | Receives |
|---|---|---|
| the group with a bed head height of 45 degrees | Other | Other: the group with a bed head height of 45 degreesThe bed head height of the patients in this group will be adjusted to 45 degrees. This group was determined as the control group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted. |
| the group with a bed head height of 30 degrees | Experimental | Other: the group with a bed head height of 30 degreesThe bed head height of the patients in this group will be adjusted to 30 degrees. This group was determined as the experimental group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participating in the research voluntarily
- Patients over the age of 18
- Patients who have undergone rhinoplasty for aesthetic purposes
- Can speak Turkish
- Patients who do not have a mental disability that may interfere with communication
Key exclusion criteria (7 listed)
- Patients who did not agree to participate in the study
- Patients under the age of 18
- Patients who underwent rhinoplasty surgery due to trauma
- Patients with mental disabilities who interfere with communication
- Patients who cannot adapt to bed height
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 |
|---|---|---|
| the group with a bed head height of 45 degreesAlso: Nursing care intervention for positioning appropriately after surgeryEdema, ecchymosis, respiratory function and sleep quality will be evaluated by giving a 45 degree head height to 30 patients determined by Randomizer.org. | Other | the group with a bed head height of 45 degrees |
| the group with a bed head height of 30 degreesAlso: Nursing care intervention for positioning appropriately after surgeryEdema, ecchymosis, respiratory function and sleep quality will be evaluated by giving 30 degrees of bed head height to 30 patients determined by Randomizer.org. | Other | the group with a bed head height of 30 degrees |
Primary outcome
Periorbital edema score
Time frame: 1 hour after surgery
This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Periorbital edema score
Time frame: 4 hours after surgery
This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Periorbital edema score
Time frame: 24th hour after surgery
This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour.
Right and left periorbital ecchymosis score
Time frame: 1 hour after surgery
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
Right and left periorbital ecchymosis score
Time frame: 4 hours after surgery
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
Right and left periorbital ecchymosis score
Time frame: 24th hour after surgery
Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid.
6 secondary outcomes
Monitoring the change in fever
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in systolic blood pressure
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in diastolic blood pressure
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in pulse
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Monitoring the change in oxygen saturation
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Richard's Campbell Sleep Scale
Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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.
Şevval Polat principal investigator
Uzunmehmet chest and occupational diseases hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the group with a bed head height of 45 degrees and the group with a bed head height of 30 degrees in people with Rhinoplasty, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polat (05388480455, sevvalseyrek74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periorbital edema score (time frame: 1 hour after surgery). The study lists 6 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 25 Jan 2023.