TourniquetNCT03899116
Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients
An observational study of Tourniquet, run by Cairo University at 1 site in Egypt.
Trial summary
Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Tourniquet
- What is being tested?
- deflation of pneumatic tourniquet
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to Jan 2020
- Phase
- Observational
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet
Who may be able to join
- scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet
Who cannot join
- BMI ≥35Kg/ m2
- patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
- contraindication to tourniquet insertion
- patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Cairo, 115711
yasmin ibrahim, 1006719987, yalnaby@yahoo.com
About this study
Official title: Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice
Read the detailed description
Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:
G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.
G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.
G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.
- Conditions
- Tourniquet
- Being tested
- deflation of pneumatic tourniquet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deflation of pneumatic tourniquetOther
gradual deflation with variable degrees
| Study group | Role | What they receive |
|---|---|---|
| G50 | The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation. Receives: Other: deflation of pneumatic tourniquet | |
| G100 | The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation. Receives: Other: deflation of pneumatic tourniquet | |
| G0 | The tourniquet cuff will be released till complete deflation. Receives: Other: deflation of pneumatic tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.
Measured: 15 minutes after start of deflation of cuff
Secondary outcomes (2)
hypotension
incidence of post tourniquet hypotension
Measured: 15 minutes after start of deflation of cuff
cardiac output
cardiac output after starting deflation using non invasive electrical cardiometry
Measured: 15 minutes after start of deflation of cuff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Aug 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TourniquetStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Hassab elnaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899116
- Sponsor's protocol ID
- 101-2018
- Status last verified
- Jul 2019
- First submitted
- 6 Mar 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
- ClinicalTrials.gov ID
- NCT03899116
- Acronym / sponsor ID
- 101-2018
- Conditions
- Tourniquet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 2 Apr 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.
Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice
Detailed description
Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:
G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.
G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.
G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G50 | – | Other: deflation of pneumatic tourniquetThe tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation. |
| G100 | – | Other: deflation of pneumatic tourniquetThe tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation. |
| G0 | – | Other: deflation of pneumatic tourniquetThe tourniquet cuff will be released till complete deflation. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients above 50 years scheduled for orthopedic lower limb surgery under pneumatic tourniquet
Key inclusion criteria (1 listed)
- scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet
Key exclusion criteria (4 listed)
- BMI ≥35Kg/ m2
- patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
- contraindication to tourniquet insertion
- patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).
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 |
|---|---|---|
| deflation of pneumatic tourniquetgradual deflation with variable degrees | Other | G0, G100, G50 |
Primary outcome
mean arterial blood pressure
Time frame: 15 minutes after start of deflation of cuff
The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.
2 secondary outcomes
hypotension
Time frame: 15 minutes after start of deflation of cuff
cardiac output
Time frame: 15 minutes after start of deflation of cuff
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Tourniquet
Enrolling by invitation
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
Local Epinephrine in Myomectomy
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Not yet recruiting
Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
Not yet recruiting
Effect of Tourniquet Use on the Pivot Shift Test
Anterior Cruciate Ligament Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourniquet, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 4 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 Jul 2019. 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 Egypt. 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 yasmin ibrahim (01006719987, yalnaby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean arterial blood pressure (time frame: 15 minutes after start of deflation of cuff). 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 Jul 2019.