Shoulder InjuriesNCT04671537
The Effects of Preloading Before Beach Chair Position
A study testing Preloading with crystalloid fluid in people with Shoulder Injuries and Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. The study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injuries, Anesthesia, Hemodynamic Instability
- What is being tested?
- Preloading with crystalloid fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Jan 2020
- 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
- undergoing elective arthroscopic shoulder surgery in the BCP,
- age older than 18 years and younger than 65 years,
- the American Society of Anesthesiologist (ASA) physical status of I or II,
- accepting the study protocol.
Who cannot join
- preoperative arrhythmia,
- significant heart failure
- valvular heart disease,
- preexisting cerebrovascular disease,
- deciding to switch to open surgery,
- vasopressor infusion during the surgery,
- using angiotensin converting enzyme inhibitors (ACEI) orangiotensin receptor blockers (ARB) as antihypertensive medication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unıversity, Istanbul Faculty of Medicine
Istanbul
About this study
Official title: Effectiveness of Preloading Before Beach Chair Position on Patients Undergoing Arthroscopic Shoulder Surgery: Randomized Controlled Trial
The main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. The study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia.
Read the detailed description
Keeping patients in normovolemic state and hemodynamically stable in anesthesia and intensive care practice are important goals of anesthesiologist. It is known that hypotension that develops after taking patients to the beach chair position has a negative effect on cerebral oxygenation. Aggressive fluid regimes using to prevent hypotension can cause glycocalyx damage, edema and organ dysfunction. Also hypertension seconday to vasopressor therapy can cause bleeding at the surgical site and impaired surgical visualization during the arthroscopic shoulder surgery.
In the literature, there are studies examine whether the hypotension is the result of decreased cardiac output or decreased systemic resistance and what should be the optimal treatment , but as far as investigators know, there is no study about effects of preloading before the beach chair position on hemodynamic parameters.
- Conditions
- Shoulder Injuries, Anesthesia, Hemodynamic Instability
- Being tested
- Preloading with crystalloid fluid
- Keywords
- beach chair position, arthroscopic shoulder surgery, preloading, hemodynamic stability, postoperative nausea and vomiting
- Medical subject headings
- Shoulder Injuries, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preloading with crystalloid fluidDrug
crystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients
| Study group | Role | What they receive |
|---|---|---|
| Study group (preloading with crystalloid fluid - isotonic solution) | Experimental | Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight Receives: Drug: Preloading with crystalloid fluid |
| Control group (not preloading) | No intervention | no preloading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
(mmHg)
Measured: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Cardiac output
(L/min)
Measured: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Stroke volume variation
(%) data obtained from arterial contour analysis
Measured: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Heart rate
bpm
Measured: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Secondary outcomes (5)
Postoperative nausea and vomiting
PONV rates
Measured: in postoperative first day
Surgical satisfaction rate
Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)
Measured: in postoperative first day
The duration of anesthesia and surgery
The duration of anesthesia and surgery (min)
Measured: during surgery
Ephedrine usage
total ephedrine dose (mg) used during surgery
Measured: during surgery
Total amount of crystalloid and colloid
Total amount of crystalloid and colloid (ml)
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group - Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Huru Ceren Gokduman, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyElif Aygun, MD, Study chair, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyNur Canbolat, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyMert Canbaz, MD, Study director, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyAli Ersen, MD, Study chair, Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and OrthopedicsMehmet Buget, MD, Study chair, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671537
- Sponsor's protocol ID
- 2018/166711
- Other IDs
- 2018
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen SL, Lyngeraa TS, Maschmann CP, Van Lieshout JJ, Pott FC. Cardiovascular consequence of reclining vs. sitting beach-chair body position for induction of anesthesia. Front Physiol. 2014 May 19;5:187. doi: 10.3389/fphys.2014.00187. eCollection 2014.
PubMed 24904427Woodcock TE, Woodcock TM. Revised Starling equation and the glycocalyx model of transvascular fluid exchange: an improved paradigm for prescribing intravenous fluid therapy. Br J Anaesth. 2012 Mar;108(3):384-94. doi: 10.1093/bja/aer515. Epub 2012 Jan 29.
PubMed 22290457Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.
PubMed 24472443
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preloading Before Beach Chair Position on Patients Undergoing Arthroscopic Shoulder Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04671537
- Acronym / sponsor ID
- 2018/166711
- Conditions
- Shoulder Injuries, Anesthesia, Hemodynamic Instability
- Keywords
- beach chair position, arthroscopic shoulder surgery, preloading, hemodynamic stability, postoperative nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Dec 2020 (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 main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. The study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia.
Detailed description
Keeping patients in normovolemic state and hemodynamically stable in anesthesia and intensive care practice are important goals of anesthesiologist. It is known that hypotension that develops after taking patients to the beach chair position has a negative effect on cerebral oxygenation. Aggressive fluid regimes using to prevent hypotension can cause glycocalyx damage, edema and organ dysfunction. Also hypertension seconday to vasopressor therapy can cause bleeding at the surgical site and impaired surgical visualization during the arthroscopic shoulder surgery.
In the literature, there are studies examine whether the hypotension is the result of decreased cardiac output or decreased systemic resistance and what should be the optimal treatment , but as far as investigators know, there is no study about effects of preloading before the beach chair position on hemodynamic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study group - Control group
| Arm | Type | Receives |
|---|---|---|
| Study group (preloading with crystalloid fluid - isotonic solution) | Experimental | Drug: Preloading with crystalloid fluidPreloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight |
| Control group (not preloading) | No intervention | –no preloading |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing elective arthroscopic shoulder surgery in the BCP,
- age older than 18 years and younger than 65 years,
- the American Society of Anesthesiologist (ASA) physical status of I or II,
- accepting the study protocol.
Key exclusion criteria (7 listed)
- preoperative arrhythmia,
- significant heart failure
- valvular heart disease,
- preexisting cerebrovascular disease,
- deciding to switch to open surgery,
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 |
|---|---|---|
| Preloading with crystalloid fluidcrystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients | Drug | Study group (preloading with crystalloid fluid - isotonic solution) |
Primary outcome
Mean arterial pressure
Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(mmHg)
Cardiac output
Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(L/min)
Stroke volume variation
Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(%) data obtained from arterial contour analysis
Heart rate
Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
bpm
5 secondary outcomes
Postoperative nausea and vomiting
Time frame: in postoperative first day
Surgical satisfaction rate
Time frame: in postoperative first day
The duration of anesthesia and surgery
Time frame: during surgery
Ephedrine usage
Time frame: during surgery
Total amount of crystalloid and colloid
Time frame: during surgery
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 17 Dec 2020.
- Background: PubMed 24904427Larsen SL, Lyngeraa TS, Maschmann CP, Van Lieshout JJ, Pott FC. Cardiovascular consequence of reclining vs. sitting beach-chair body position for induction of anesthesia. Front Physiol. 2014 May 19;5:187. doi: 10.3389/fphys.2014.00187. eCollection 2014.
- Background: PubMed 22290457Woodcock TE, Woodcock TM. Revised Starling equation and the glycocalyx model of transvascular fluid exchange: an improved paradigm for prescribing intravenous fluid therapy. Br J Anaesth. 2012 Mar;108(3):384-94. doi: 10.1093/bja/aer515. Epub 2012 Jan 29.
- Background: PubMed 24472443Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.
- Individual participant dataSharing planned: No
Related trials for Shoulder Injuries
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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.
Huru Ceren Gokduman, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Elif Aygun, MD study chair
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Nur Canbolat, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preloading with crystalloid fluid in people with Shoulder Injuries and Anesthesia, run by Istanbul University 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 4 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: finished, as of the sponsor's last update on 17 Dec 2020. 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?
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?
Mean arterial pressure (time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671537, which also lists 3 linked publications.
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 17 Dec 2020.