Pneumatic TourniquetNCT03473106
Effect of Tourniquet Use on Muscle Thigh Function.
A study testing Pneumatic tourniquet use in people with Pneumatic Tourniquet and Muscle Weakness, run by University of Chile at 1 site in Chile.
Trial summary
The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumatic Tourniquet, Muscle Weakness
- What is being tested?
- Pneumatic tourniquet use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 24 Apr 2018to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
- American Society of Anesthesiologists classification 1-3
Who cannot join
- Ambulatory surgery
- Adults who are unable to give their own consent
- Pre-existing neuropathy or myopathy
- Contraindication of tourniquet use
- Bilateral surgery
- Pregnancy
Show all 10Show fewer
- Hip, thigh, knee, leg or ankle pathologies that prevent or contraindicate using a dynamometer, tonometer or surface electromyographer
- Arterial hypertension with systolic pressures above 200mmHg
- Renal failure
- Hepatic failure
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
Daniela Bravo, MD, 56984276252, dbravoadvis@uchile.cl
Julian Aliste, MD, 56998189445, julian.aliste@uchile.cl
About this study
Official title: Effect of the Use of Tourniquet in the Thigh: a Biomechanical Analysis on the Muscular Function of the Quadriceps in the Postoperative Period.
The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is known that its use is not an innocuous measure, there is still certain degree blurriness regarding the potential metabolic and functional consequences that may result in the involved limb.
In this trial, the investigators are setting out to discriminate the effect of the pneumatic tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary isometric contraction measured at 24 hours post surgery.
- Conditions
- Pneumatic Tourniquet, Muscle Weakness
- Being tested
- Pneumatic tourniquet use
- Keywords
- Pneumatic Tourniquet, Postoperative Muscle Dysfunction
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic tourniquet useDevice
Surgery requiring a pneumatic tourniquet on the thigh
| Study group | Role | What they receive |
|---|---|---|
| Surgical Side | Experimental | Surgical side requiring the use of a pneumatic tourniquet. Receives: Device: Pneumatic tourniquet use |
| Non Surgical Side | No intervention | Contralateral side (Control Thigh). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative muscle dysfunction
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
Measured: 24 hours
Secondary outcomes (10)
Basal upper and lower extremity blood pressures
Pre spinal anesthesia measured blood pressures
Measured: Up to 2 hours pre spinal anesthesia
Upper and lower extremity blood pressures after spinal anesthesia
Post spinal anesthesia measured blood pressures
Measured: 10 minutes after spinal anesthesia
Arterial occlusion pressure
Doppler estimation of arterial occlusion pressure of the lower extremity surgical side
Measured: 10 minutes after spinal anesthesia
Pneumatic tourniquet inflation pressure
Arterial occlusion pressure plus a safety margin
Measured: 3 hours from tourniquet inflation
Pneumatic tourniquet inflation time
Time from inflation to release of the pneumatic tourniquet
Measured: 3 hours from tourniquet inflation
Quadriceps electromyographic activation profile
Basal and 24 hours (post surgery) quadriceps activation on surgical side
Measured: 24 hours
Quadriceps muscle tone
Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side
Measured: 24 hours
Thigh perimeter
Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter
Measured: 24 hours
Thigh pain
Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)
Measured: 24 hours
Postoperative measurements time
Time from pneumatic tourniquet release to postoperative muscle function measurements
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start24 Apr 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pneumatic TourniquetStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bravo Advis, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473106
- Sponsor's protocol ID
- OAIC 919/17
- Status last verified
- Jul 2019
- First submitted
- 11 Mar 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halladin NL, Zahle FV, Rosenberg J, Gogenur I. Interventions to reduce tourniquet-related ischaemic damage in orthopaedic surgery: a qualitative systematic review of randomised trials. Anaesthesia. 2014 Sep;69(9):1033-50. doi: 10.1111/anae.12664. Epub 2014 May 7.
PubMed 24800642Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
PubMed 21502865Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e.
PubMed 16492857Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
PubMed 21161177Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
PubMed 11412159Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.
PubMed 26969952Guler O, Mahirogullari M, Isyar M, Piskin A, Yalcin S, Mutlu S, Sahin B. Comparison of quadriceps muscle volume after unilateral total knee arthroplasty with and without tourniquet use. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2595-605. doi: 10.1007/s00167-015-3872-5. Epub 2015 Nov 21.
PubMed 26590567Dennis DA, Kittelson AJ, Yang CC, Miner TM, Kim RH, Stevens-Lapsley JE. Does Tourniquet Use in TKA Affect Recovery of Lower Extremity Strength and Function? A Randomized Trial. Clin Orthop Relat Res. 2016 Jan;474(1):69-77. doi: 10.1007/s11999-015-4393-8.
PubMed 26100254Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
PubMed 25979462Smith TO, Hing CB. The efficacy of the tourniquet in foot and ankle surgery? A systematic review and meta-analysis. Foot Ankle Surg. 2010 Mar;16(1):3-8. doi: 10.1016/j.fas.2009.03.006. Epub 2009 May 27.
PubMed 20152747Nicholas SJ, Tyler TF, McHugh MP, Gleim GW. The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: A prospective randomized study. Arthroscopy. 2001 Jul;17(6):603-7. doi: 10.1053/jars.2001.24854.
PubMed 11447547
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Tourniquet in the Thigh: a Biomechanical Analysis on the Muscular Function of the Quadriceps in the Postoperative Period.
- ClinicalTrials.gov ID
- NCT03473106
- Acronym / sponsor ID
- OAIC 919/17
- Conditions
- Pneumatic Tourniquet, Muscle Weakness
- Keywords
- Pneumatic Tourniquet, Postoperative Muscle Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 22 Mar 2018 (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 use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is known that its use is not an innocuous measure, there is still certain degree blurriness regarding the potential metabolic and functional consequences that may result in the involved limb.
In this trial, the investigators are setting out to discriminate the effect of the pneumatic tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary isometric contraction measured at 24 hours post surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Side | Experimental | Device: Pneumatic tourniquet useSurgical side requiring the use of a pneumatic tourniquet. |
| Non Surgical Side | No intervention | –Contralateral side (Control Thigh). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
- American Society of Anesthesiologists classification 1-3
Key exclusion criteria (10 listed)
- Ambulatory surgery
- Adults who are unable to give their own consent
- Pre-existing neuropathy or myopathy
- Contraindication of tourniquet use
- Bilateral 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 |
|---|---|---|
| Pneumatic tourniquet useSurgery requiring a pneumatic tourniquet on the thigh | Device | Surgical Side |
Primary outcome
Postoperative muscle dysfunction
Time frame: 24 hours
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
10 secondary outcomes
Basal upper and lower extremity blood pressures
Time frame: Up to 2 hours pre spinal anesthesia
Upper and lower extremity blood pressures after spinal anesthesia
Time frame: 10 minutes after spinal anesthesia
Arterial occlusion pressure
Time frame: 10 minutes after spinal anesthesia
Pneumatic tourniquet inflation pressure
Time frame: 3 hours from tourniquet inflation
Pneumatic tourniquet inflation time
Time frame: 3 hours from tourniquet inflation
Quadriceps electromyographic activation profile
Time frame: 24 hours
Quadriceps muscle tone
Time frame: 24 hours
Thigh perimeter
Time frame: 24 hours
Thigh pain
Time frame: 24 hours
Postoperative measurements time
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Results publication: PubMed 24800642Halladin NL, Zahle FV, Rosenberg J, Gogenur I. Interventions to reduce tourniquet-related ischaemic damage in orthopaedic surgery: a qualitative systematic review of randomised trials. Anaesthesia. 2014 Sep;69(9):1033-50. doi: 10.1111/anae.12664. Epub 2014 May 7.
- Results publication: PubMed 21502865Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
- Results publication: PubMed 16492857Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e.
- Results publication: PubMed 21161177Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
- Results publication: PubMed 11412159Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
- Results publication: PubMed 26969952Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.
- Results publication: PubMed 26590567Guler O, Mahirogullari M, Isyar M, Piskin A, Yalcin S, Mutlu S, Sahin B. Comparison of quadriceps muscle volume after unilateral total knee arthroplasty with and without tourniquet use. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2595-605. doi: 10.1007/s00167-015-3872-5. Epub 2015 Nov 21.
- Results publication: PubMed 26100254Dennis DA, Kittelson AJ, Yang CC, Miner TM, Kim RH, Stevens-Lapsley JE. Does Tourniquet Use in TKA Affect Recovery of Lower Extremity Strength and Function? A Randomized Trial. Clin Orthop Relat Res. 2016 Jan;474(1):69-77. doi: 10.1007/s11999-015-4393-8.
- Results publication: PubMed 25979462Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
- Results publication: PubMed 20152747Smith TO, Hing CB. The efficacy of the tourniquet in foot and ankle surgery? A systematic review and meta-analysis. Foot Ankle Surg. 2010 Mar;16(1):3-8. doi: 10.1016/j.fas.2009.03.006. Epub 2009 May 27.
- Results publication: PubMed 11447547Nicholas SJ, Tyler TF, McHugh MP, Gleim GW. The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: A prospective randomized study. Arthroscopy. 2001 Jul;17(6):603-7. doi: 10.1053/jars.2001.24854.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic tourniquet use in people with Pneumatic Tourniquet and Muscle Weakness, run by University of Chile at 1 site in Chile.
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 2 inclusion and 10 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 22 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 Chile. 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 Daniela Bravo, MD (56984276252, dbravoadvis@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative muscle dysfunction (time frame: 24 hours). 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 NCT03473106, which also lists 11 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 22 Jul 2019.