Fluid OverloadNCT03789474
Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs
A study testing HUNTLEIGH FLOWTRON ACS900 in people with Fluid Overload, run by All India Institute of Medical Sciences, Rishikesh.
Trial summary
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Overload
- What is being tested?
- HUNTLEIGH FLOWTRON ACS900
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA(American Society of Anaesthesiologists) grade I or II, of both genders
- Age group of 25 to 50 years
- Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours
Who cannot join
- Patients expected to get major blood loss
- Burns patients.
- Patients with significant cardiac diseases.
- Patients with pulmonary diseases and impaired renal function.
- Lower limb surgeries and abdominal surgeries
About this study
Official title: Impact of Intra-operative Use of Peristaltic Pneumatic Compression Device on Haemodynamics Vis-à-vis Fluid Requirement During General Anaesthesia and Surgery:A Randomized Prospective Study
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.
Read the detailed description
Induction of general anaesthesia is associated with cardiac depression and peripheral vasodilatation resulting in hypotension .This hypotension can be corrected by giving intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative period is of vital importance in overnight fasting patients to correct the fluid deficit, any fluid overload is not only counterproductive to the heart function but is associated with fluid retention in body and edema in postoperative period.
Peristaltic pneumatic compression device, a variant of intermittent sequential compression of legs, uses higher pressure and longer compression cycles to avoid venous stasis in immobilized patients. Sequential compression devices have sleeves with pockets of inflation, which works to squeeze on the appendage in a milking action .The most distal areas will inflate initially, and the subsequent pockets will follow in the same manner. The primary aim of the device is to squeeze blood from the underlying deep veins to proximal side. When the inflatable sleeves deflate, the veins will replenish with blood. The intermittent compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic Compression of the legs significantly reduces fluid demand and enhances stability during minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to support fluid restriction regimens during surgery .
- Conditions
- Fluid Overload
- Being tested
- HUNTLEIGH FLOWTRON ACS900
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUNTLEIGH FLOWTRON ACS900Device
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | No intervention was done ,served as a control group. |
| Group B | Experimental | Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used. Receives: Device: HUNTLEIGH FLOWTRON ACS900 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate at T0
heart rate monitoring at T0
Measured: 15 minutes pre induction
Heart Rate at T1
heart rate monitoring at T1
Measured: post induction heart rate
Heart Rate at T2
heart rate monitoring at T2
Measured: 15 minutes after induction
Heart Rate at T3
heart rate monitoring at T3
Measured: 30 minutes after induction
Heart Rate at T4
heart rate monitoring at T4
Measured: 60 minutes after induction
Heart Rate at T5
heart rate monitoring at T5
Measured: 120 minutes after induction
Heart Rate at T6
heart rate monitoring at T6
Measured: post operative period after 30 min in post anaesthesia care unit
Systolic Blood Pressure at T0
systolic blood pressure measurement at T0
Measured: 15 min before induction
Systolic Blood Pressure at T1
systolic blood pressure measurement at T1
Measured: post induction
Systolic Blood Pressure at T2
systolic blood pressure measurement at T2
Measured: 15 min after induction
Systolic Blood Pressure at T3
systolic blood pressure measurement at T3
Measured: 30 min after induction
Systolic Blood Pressure at T4
systolic blood pressure measurement at T4
Measured: 60 min after induction
Systolic Blood Pressure at T5
systolic blood pressure measurement at T5
Measured: 120 min after induction
Systolic Blood Pressure at T6
systolic blood pressure measurement at T6
Measured: post operative period 30 min in post asnaesthesia care unit
Diastolic Blood Presure at T0
Diastolic blood pressure measurement at T0
Measured: 15 minutes before induction
Diastolic Blood Pressure at T1
Diastolic blood pressure measurement at T1
Measured: immediately after induction
Diastolic Blood Pressure at T2
Diastolic blood pressure measurement at T2
Measured: 15 minutes after induction
Diastolic Blood Pressure at T3
Diastolic blood pressure measurement at T3
Measured: 30 minutes after induction
Diastolic Blood Pressure at T4
Diastolic blood pressure measurement at T4
Measured: 60 minutes after induction
Diastolic Blood Pressure at T5
Diastolic blood pressure measurement at T5
Measured: 120 minutes after induction
Diastolic Blood Pressure at T6
Diastolic blood pressure measurement at T6
Measured: post induction 30 min in post anaesthesia care unit
Mean Blood Pressure at T0
Mean blood pressure measurement at T0
Measured: 15 minutes pre induction
Mean Blood Pressure at T1
Mean blood pressure measurement at T1
Measured: immediately after induction
Mean Blood Pressure at T2
Mean blood pressure measurement at T2
Measured: 15 minutes after induction
Mean Blood Pressure at T3
Mean blood pressure measurement at T3
Measured: 30 minutes after induction
Mean Blood Pressure at T4
Mean blood pressure measurement at T4
Measured: 60 minutes after induction
Mean Blood Pressure at T5
Mean blood pressure measurement at T5
Measured: 120 minutes after induction
Mean Blood Pressure at T6
Mean blood pressure measurement at T6
Measured: post operative 30 min in post anaesthesia care unit
Femoral Vein Velocity at T0
Femoral vein velocity measuement at T0
Measured: 15 minutes pre induction
Femoral Vein Velocity at T2
Femoral vein velocity measurement at T2
Measured: 15 minutes after induction
Femoral Vein Velocity at T6
Femoral vein velocity measurement at T6
Measured: after 30 minutes in post anaesthesia care unit
Femoral Vein Velocity Variance
the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage
Measured: 15 minutes pre induction to 30 minutes in post anaesthesia care unit
Femoral Artery Velocity at T0
Femoral artery velocity measurement at T0
Measured: 15 minutes pre induction
Femoral Artery Velocity at T2
Femoral artery velocity measurement at T2
Measured: 15 minutes after induction
Femoral Artery Velocity at T6
Femoral artery velocity measurement at T6
Measured: after 30 minutes in post anaesthesia care unit
Inferior Venacava Diameter (Maximum) at T0
inferior venacava diameter (maximum) meaurement at T0
Measured: 15 min pre induction
Inferior Venacava Diameter (Maximum) at T2
inferior venacava diameter (maximum) meaurement at T2
Measured: 15 min after induction
Inferior Venacava Diameter (Maximum) at T6
inferior venacava diameter (maximum) meaurement at T6
Measured: after 30 min in post anaesthesia care unit
Inferior Venacava Diameter (Minimum) at T0
inferior venacava diameter (minimum) meaurement at T0
Measured: 15 min pre induction
Inferior Venacava Diameter (Minimum) at T2
inferior venacava diameter (minimum) meaurement at T2
Measured: 15 min after induction
Inferior Venacava Diameter (Minimum) at T6
inferior venacava diameter (minimum) meaurement at T6
Measured: after 30 min in post anaesthesia care unit
Inferior Venacava Diameter Collapsibility Index at T0
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
Measured: 15 min pre induction
Inferior Venacava Diameter Distensibility Index at T2
the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .
Measured: 15 min after induction
Inferior Venacava Diameter Collapsibility Index at T6
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
Measured: after 30 minutes in post anaesthesia care unit
FLUID REQUIREMENT (Cumulative)
fluid requirement (cumulative) during the operative period.
Measured: operative period
Blood Loss During Operation
Total blood loss during operation
Measured: During operating procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Rishikesh
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Masaipeta Kesari, All India Institute of Medical Sciences, Rishikesh
- Investigators
- Mukesh Tripathi, MD, Principal investigator, All India Institute of Medical Sciences, Rishikesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789474
- Sponsor's protocol ID
- AIIMSRishikesh
- Status last verified
- Aug 2020
- First submitted
- 27 Dec 2018
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: study protocol,stastical analysis plan,informed consent form.
Publications
Kiefer N, Theis J, Putensen-Himmer G, Hoeft A, Zenker S. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study. Anesthesiology. 2011 Mar;114(3):536-44. doi: 10.1097/ALN.0b013e31820c3973.
PubMed 21307764Kaufmann KB, Stein L, Bogatyreva L, Ulbrich F, Kaifi JT, Hauschke D, Loop T, Goebel U. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial. Br J Anaesth. 2017 Jun 1;118(6):852-861. doi: 10.1093/bja/aew447.
PubMed 28575331Meng L, Heerdt PM. Perioperative goal-directed haemodynamic therapy based on flow parameters: a concept in evolution. Br J Anaesth. 2016 Dec;117(suppl 3):iii3-iii17. doi: 10.1093/bja/aew363.
PubMed 27940452Millard JA, Hill BB, Cook PS, Fenoglio ME, Stahlgren LH. Intermittent sequential pneumatic compression in prevention of venous stasis associated with pneumoperitoneum during laparoscopic cholecystectomy. Arch Surg. 1993 Aug;128(8):914-8; discussion 918-9. doi: 10.1001/archsurg.1993.01420200088016.
PubMed 8343064
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intra-operative Use of Peristaltic Pneumatic Compression Device on Haemodynamics Vis-à-vis Fluid Requirement During General Anaesthesia and Surgery:A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03789474
- Acronym / sponsor ID
- AIIMSRishikesh
- Conditions
- Fluid Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, RishikeshOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.
Detailed description
Induction of general anaesthesia is associated with cardiac depression and peripheral vasodilatation resulting in hypotension .This hypotension can be corrected by giving intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative period is of vital importance in overnight fasting patients to correct the fluid deficit, any fluid overload is not only counterproductive to the heart function but is associated with fluid retention in body and edema in postoperative period.
Peristaltic pneumatic compression device, a variant of intermittent sequential compression of legs, uses higher pressure and longer compression cycles to avoid venous stasis in immobilized patients. Sequential compression devices have sleeves with pockets of inflation, which works to squeeze on the appendage in a milking action .The most distal areas will inflate initially, and the subsequent pockets will follow in the same manner. The primary aim of the device is to squeeze blood from the underlying deep veins to proximal side. When the inflatable sleeves deflate, the veins will replenish with blood. The intermittent compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic Compression of the legs significantly reduces fluid demand and enhances stability during minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to support fluid restriction regimens during surgery .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –No intervention was done ,served as a control group. |
| Group B | Experimental | Device: HUNTLEIGH FLOWTRON ACS900Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA(American Society of Anaesthesiologists) grade I or II, of both genders
- Age group of 25 to 50 years
- Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours
Key exclusion criteria (5 listed)
- Patients expected to get major blood loss
- Burns patients.
- Patients with significant cardiac diseases.
- Patients with pulmonary diseases and impaired renal function.
- Lower limb surgeries and abdominal surgeries
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 |
|---|---|---|
| HUNTLEIGH FLOWTRON ACS900 | Device | Group B |
Primary outcome
Heart Rate at T0
Time frame: 15 minutes pre induction
heart rate monitoring at T0
Heart Rate at T1
Time frame: post induction heart rate
heart rate monitoring at T1
Heart Rate at T2
Time frame: 15 minutes after induction
heart rate monitoring at T2
Heart Rate at T3
Time frame: 30 minutes after induction
heart rate monitoring at T3
Heart Rate at T4
Time frame: 60 minutes after induction
heart rate monitoring at T4
Heart Rate at T5
Time frame: 120 minutes after induction
heart rate monitoring at T5
Heart Rate at T6
Time frame: post operative period after 30 min in post anaesthesia care unit
heart rate monitoring at T6
Systolic Blood Pressure at T0
Time frame: 15 min before induction
systolic blood pressure measurement at T0
Systolic Blood Pressure at T1
Time frame: post induction
systolic blood pressure measurement at T1
Systolic Blood Pressure at T2
Time frame: 15 min after induction
systolic blood pressure measurement at T2
Systolic Blood Pressure at T3
Time frame: 30 min after induction
systolic blood pressure measurement at T3
Systolic Blood Pressure at T4
Time frame: 60 min after induction
systolic blood pressure measurement at T4
Systolic Blood Pressure at T5
Time frame: 120 min after induction
systolic blood pressure measurement at T5
Systolic Blood Pressure at T6
Time frame: post operative period 30 min in post asnaesthesia care unit
systolic blood pressure measurement at T6
Diastolic Blood Presure at T0
Time frame: 15 minutes before induction
Diastolic blood pressure measurement at T0
Diastolic Blood Pressure at T1
Time frame: immediately after induction
Diastolic blood pressure measurement at T1
Diastolic Blood Pressure at T2
Time frame: 15 minutes after induction
Diastolic blood pressure measurement at T2
Diastolic Blood Pressure at T3
Time frame: 30 minutes after induction
Diastolic blood pressure measurement at T3
Diastolic Blood Pressure at T4
Time frame: 60 minutes after induction
Diastolic blood pressure measurement at T4
Diastolic Blood Pressure at T5
Time frame: 120 minutes after induction
Diastolic blood pressure measurement at T5
Diastolic Blood Pressure at T6
Time frame: post induction 30 min in post anaesthesia care unit
Diastolic blood pressure measurement at T6
Mean Blood Pressure at T0
Time frame: 15 minutes pre induction
Mean blood pressure measurement at T0
Mean Blood Pressure at T1
Time frame: immediately after induction
Mean blood pressure measurement at T1
Mean Blood Pressure at T2
Time frame: 15 minutes after induction
Mean blood pressure measurement at T2
Mean Blood Pressure at T3
Time frame: 30 minutes after induction
Mean blood pressure measurement at T3
Mean Blood Pressure at T4
Time frame: 60 minutes after induction
Mean blood pressure measurement at T4
Mean Blood Pressure at T5
Time frame: 120 minutes after induction
Mean blood pressure measurement at T5
Mean Blood Pressure at T6
Time frame: post operative 30 min in post anaesthesia care unit
Mean blood pressure measurement at T6
Femoral Vein Velocity at T0
Time frame: 15 minutes pre induction
Femoral vein velocity measuement at T0
Femoral Vein Velocity at T2
Time frame: 15 minutes after induction
Femoral vein velocity measurement at T2
Femoral Vein Velocity at T6
Time frame: after 30 minutes in post anaesthesia care unit
Femoral vein velocity measurement at T6
Femoral Vein Velocity Variance
Time frame: 15 minutes pre induction to 30 minutes in post anaesthesia care unit
the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage
Femoral Artery Velocity at T0
Time frame: 15 minutes pre induction
Femoral artery velocity measurement at T0
Femoral Artery Velocity at T2
Time frame: 15 minutes after induction
Femoral artery velocity measurement at T2
Femoral Artery Velocity at T6
Time frame: after 30 minutes in post anaesthesia care unit
Femoral artery velocity measurement at T6
Inferior Venacava Diameter (Maximum) at T0
Time frame: 15 min pre induction
inferior venacava diameter (maximum) meaurement at T0
Inferior Venacava Diameter (Maximum) at T2
Time frame: 15 min after induction
inferior venacava diameter (maximum) meaurement at T2
Inferior Venacava Diameter (Maximum) at T6
Time frame: after 30 min in post anaesthesia care unit
inferior venacava diameter (maximum) meaurement at T6
Inferior Venacava Diameter (Minimum) at T0
Time frame: 15 min pre induction
inferior venacava diameter (minimum) meaurement at T0
Inferior Venacava Diameter (Minimum) at T2
Time frame: 15 min after induction
inferior venacava diameter (minimum) meaurement at T2
Inferior Venacava Diameter (Minimum) at T6
Time frame: after 30 min in post anaesthesia care unit
inferior venacava diameter (minimum) meaurement at T6
Inferior Venacava Diameter Collapsibility Index at T0
Time frame: 15 min pre induction
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
Inferior Venacava Diameter Distensibility Index at T2
Time frame: 15 min after induction
the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .
Inferior Venacava Diameter Collapsibility Index at T6
Time frame: after 30 minutes in post anaesthesia care unit
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
FLUID REQUIREMENT (Cumulative)
Time frame: operative period
fluid requirement (cumulative) during the operative period.
Blood Loss During Operation
Time frame: During operating procedure
Total blood loss during operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21307764Kiefer N, Theis J, Putensen-Himmer G, Hoeft A, Zenker S. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study. Anesthesiology. 2011 Mar;114(3):536-44. doi: 10.1097/ALN.0b013e31820c3973.
- Results publication: PubMed 28575331Kaufmann KB, Stein L, Bogatyreva L, Ulbrich F, Kaifi JT, Hauschke D, Loop T, Goebel U. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial. Br J Anaesth. 2017 Jun 1;118(6):852-861. doi: 10.1093/bja/aew447.
- Results publication: PubMed 27940452Meng L, Heerdt PM. Perioperative goal-directed haemodynamic therapy based on flow parameters: a concept in evolution. Br J Anaesth. 2016 Dec;117(suppl 3):iii3-iii17. doi: 10.1093/bja/aew363.
- Results publication: PubMed 8343064Millard JA, Hill BB, Cook PS, Fenoglio ME, Stahlgren LH. Intermittent sequential pneumatic compression in prevention of venous stasis associated with pneumoperitoneum during laparoscopic cholecystectomy. Arch Surg. 1993 Aug;128(8):914-8; discussion 918-9. doi: 10.1001/archsurg.1993.01420200088016.
- Individual participant dataSharing planned: Yes. study protocol,stastical analysis plan,informed consent form.
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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.
Mukesh Tripathi, MD principal investigator
All India Institute of Medical Sciences, Rishikesh
Questions about this trial
What is this clinical trial studying?
A study testing HUNTLEIGH FLOWTRON ACS900 in people with Fluid Overload, run by All India Institute of Medical Sciences, Rishikesh.
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 3 inclusion and 5 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 21 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heart Rate at T0 (time frame: 15 minutes pre induction). The study lists 46 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 NCT03789474, which also lists 4 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 21 Aug 2020.