N/A N=60 Randomized Triple-blind Prevention

Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs

Fluid Overload

Bottom Line

View on ClinicalTrials.gov: NCT03789474 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Heart Rate at T0 — 85.23; 88.833 beats per minute — p=.443

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HUNTLEIGH FLOWTRON ACS900 (Device)
Age: Adult · 25+ yrs
Sex: All
Sponsor: All India Institute of Medical Sciences, Rishikesh
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate at T0	85.23; 88.833	.443
PRIMARY Heart Rate at T1	79.60; 88.13	.063
PRIMARY Heart Rate at T2	79.97; 88.57	.057
PRIMARY Heart Rate at T3	76.70; 84.77	.038 sig
PRIMARY Heart Rate at T4	77.40; 83.56	.072
PRIMARY Heart Rate at T5	77.53; 82.17	.189
PRIMARY Heart Rate at T6	85.06; 88.23	.358
PRIMARY Systolic Blood Pressure at T0	119.06; 122.1	.406
PRIMARY Systolic Blood Pressure at T1	102.33; 106.80	.256
PRIMARY Systolic Blood Pressure at T2	100.73; 106.93	.066
PRIMARY Systolic Blood Pressure at T3	106.23; 109.90	.316
PRIMARY Systolic Blood Pressure at T4	111.10; 111.23	.971
PRIMARY Systolic Blood Pressure at T5	108.86; 115.70	.030 sig
PRIMARY Systolic Blood Pressure at T6	118.80; 126.03	.009 sig
PRIMARY Diastolic Blood Presure at T0	76.00; 72.23	.704
PRIMARY Diastolic Blood Pressure at T1	66.30; 69.33	.350
PRIMARY Diastolic Blood Pressure at T2	65.37; 66.53	.708
PRIMARY Diastolic Blood Pressure at T3	69.46; 68.13	.711
PRIMARY Diastolic Blood Pressure at T4	69.36; 69.16	.956
PRIMARY Diastolic Blood Pressure at T5	66.63; 70.80	.139
PRIMARY Diastolic Blood Pressure at T6	70.66; 75.80	.035 sig
PRIMARY Mean Blood Pressure at T0	90.04; 92.19	.502
PRIMARY Mean Blood Pressure at T1	78.38; 81.82	.350
PRIMARY Mean Blood Pressure at T2	77.38; 79.99	.380
PRIMARY Mean Blood Pressure at T3	82.42; 82.05	.914
PRIMARY Mean Blood Pressure at T4	83.55; 83.19	.915
PRIMARY Mean Blood Pressure at T5	81.16; 85.76	.087
PRIMARY Mean Blood Pressure at T6	86.71; 92.54	.011 sig
PRIMARY Femoral Vein Velocity at T0	29.35; 31.31	.207
PRIMARY Femoral Vein Velocity at T2	27.79; 33.61	.142
PRIMARY Femoral Vein Velocity at T6	28.35; 31.92	.021 sig
PRIMARY Femoral Vein Velocity Variance	-5.419; 7.188	0.0001 sig
PRIMARY Femoral Artery Velocity at T0	69.15; 76.25	.030 sig
PRIMARY Femoral Artery Velocity at T2	67.74; 73.91	.048 sig
PRIMARY Femoral Artery Velocity at T6	69.82; 76.63	.047 sig
PRIMARY Inferior Venacava Diameter (Maximum) at T0	1.16; 1.26	.019 sig
PRIMARY Inferior Venacava Diameter (Maximum) at T2	1.27; 1.27	.000 sig
PRIMARY Inferior Venacava Diameter (Maximum) at T6	1.19; 1.31	.004 sig
PRIMARY Inferior Venacava Diameter (Minimum) at T0	1.06; 1.15	.020 sig
PRIMARY Inferior Venacava Diameter (Minimum) at T2	1.02; 1.15	.000 sig
PRIMARY Inferior Venacava Diameter (Minimum) at T6	1.11; 1.18	.053
PRIMARY Inferior Venacava Diameter Collapsibility Index at T0	9.06; 9.32	.746
PRIMARY Inferior Venacava Diameter Distensibility Index at T2	11.05; 8.39	.006 sig
PRIMARY Inferior Venacava Diameter Collapsibility Index at T6	7.04; 10.03	.003 sig
PRIMARY FLUID REQUIREMENT (Cumulative)	1456.67; 1291.66	0.043 sig
PRIMARY Blood Loss During Operation	99.67; 116.67	.160

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03789474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.