NCT03789474

Brief Summary

Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

December 27, 2018

Results QC Date

May 5, 2020

Last Update Submit

August 11, 2020

Conditions

Fluid Overload

Outcome Measures

Primary Outcomes (46)

  • Heart Rate at T0

    heart rate monitoring at T0

    15 minutes pre induction

  • Heart Rate at T1

    heart rate monitoring at T1

    post induction heart rate

  • Heart Rate at T2

    heart rate monitoring at T2

    15 minutes after induction

  • Heart Rate at T3

    heart rate monitoring at T3

    30 minutes after induction

  • Heart Rate at T4

    heart rate monitoring at T4

    60 minutes after induction

  • Heart Rate at T5

    heart rate monitoring at T5

    120 minutes after induction

  • Heart Rate at T6

    heart rate monitoring at T6

    post operative period after 30 min in post anaesthesia care unit

  • Systolic Blood Pressure at T0

    systolic blood pressure measurement at T0

    15 min before induction

  • Systolic Blood Pressure at T1

    systolic blood pressure measurement at T1

    post induction

  • Systolic Blood Pressure at T2

    systolic blood pressure measurement at T2

    15 min after induction

  • Systolic Blood Pressure at T3

    systolic blood pressure measurement at T3

    30 min after induction

  • Systolic Blood Pressure at T4

    systolic blood pressure measurement at T4

    60 min after induction

  • Systolic Blood Pressure at T5

    systolic blood pressure measurement at T5

    120 min after induction

  • Systolic Blood Pressure at T6

    systolic blood pressure measurement at T6

    post operative period 30 min in post asnaesthesia care unit

  • Diastolic Blood Presure at T0

    Diastolic blood pressure measurement at T0

    15 minutes before induction

  • Diastolic Blood Pressure at T1

    Diastolic blood pressure measurement at T1

    immediately after induction

  • Diastolic Blood Pressure at T2

    Diastolic blood pressure measurement at T2

    15 minutes after induction

  • Diastolic Blood Pressure at T3

    Diastolic blood pressure measurement at T3

    30 minutes after induction

  • Diastolic Blood Pressure at T4

    Diastolic blood pressure measurement at T4

    60 minutes after induction

  • Diastolic Blood Pressure at T5

    Diastolic blood pressure measurement at T5

    120 minutes after induction

  • Diastolic Blood Pressure at T6

    Diastolic blood pressure measurement at T6

    post induction 30 min in post anaesthesia care unit

  • Mean Blood Pressure at T0

    Mean blood pressure measurement at T0

    15 minutes pre induction

  • Mean Blood Pressure at T1

    Mean blood pressure measurement at T1

    immediately after induction

  • Mean Blood Pressure at T2

    Mean blood pressure measurement at T2

    15 minutes after induction

  • Mean Blood Pressure at T3

    Mean blood pressure measurement at T3

    30 minutes after induction

  • Mean Blood Pressure at T4

    Mean blood pressure measurement at T4

    60 minutes after induction

  • Mean Blood Pressure at T5

    Mean blood pressure measurement at T5

    120 minutes after induction

  • Mean Blood Pressure at T6

    Mean blood pressure measurement at T6

    post operative 30 min in post anaesthesia care unit

  • Femoral Vein Velocity at T0

    Femoral vein velocity measuement at T0

    15 minutes pre induction

  • Femoral Vein Velocity at T2

    Femoral vein velocity measurement at T2

    15 minutes after induction

  • Femoral Vein Velocity at T6

    Femoral vein velocity measurement at T6

    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

    15 minutes pre induction to 30 minutes in post anaesthesia care unit

  • Femoral Artery Velocity at T0

    Femoral artery velocity measurement at T0

    15 minutes pre induction

  • Femoral Artery Velocity at T2

    Femoral artery velocity measurement at T2

    15 minutes after induction

  • Femoral Artery Velocity at T6

    Femoral artery velocity measurement at T6

    after 30 minutes in post anaesthesia care unit

  • Inferior Venacava Diameter (Maximum) at T0

    inferior venacava diameter (maximum) meaurement at T0

    15 min pre induction

  • Inferior Venacava Diameter (Maximum) at T2

    inferior venacava diameter (maximum) meaurement at T2

    15 min after induction

  • Inferior Venacava Diameter (Maximum) at T6

    inferior venacava diameter (maximum) meaurement at T6

    after 30 min in post anaesthesia care unit

  • Inferior Venacava Diameter (Minimum) at T0

    inferior venacava diameter (minimum) meaurement at T0

    15 min pre induction

  • Inferior Venacava Diameter (Minimum) at T2

    inferior venacava diameter (minimum) meaurement at T2

    15 min after induction

  • Inferior Venacava Diameter (Minimum) at T6

    inferior venacava diameter (minimum) meaurement at T6

    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

    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 .

    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

    after 30 minutes in post anaesthesia care unit

  • FLUID REQUIREMENT (Cumulative)

    fluid requirement (cumulative) during the operative period.

    operative period

  • Blood Loss During Operation

    Total blood loss during operation

    During operating procedure

Study Arms (2)

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.

Device: HUNTLEIGH FLOWTRON ACS900

Interventions

HUNTLEIGH FLOWTRON ACS900DEVICE
Group B

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 21307764RESULT

  • Kaufmann 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.

    PMID: 28575331RESULT

  • Meng 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.

    PMID: 27940452RESULT

  • Millard 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.

    PMID: 8343064RESULT

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

* Outcome of the patients was not studied. * The patients studied underwent procedures for short duration of 2-3 hours. Longer procedures were not taken into consideration and the applicability and efficacy in those procedures was not evaluated.

Results Point of Contact

Title
Dr M KESARI
Organization
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH,UTTARAKHAND,INDIA.
kesyellow@yahoo.com
7093005219

Study Officials

  • Mukesh Tripathi, MD

    All India Institute of Medical Sciences, Rishikesh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior resident,Principal Investigator,Department of Anaesthesiology, All India institute of Medical Sciences, Rishikesh.

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 28, 2018

Study Start

January 1, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

August 21, 2020

Results First Posted

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

study protocol,stastical analysis plan,informed consent form.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
june 2020 till june 2021
Access Criteria
after obtaining consent.