Trial Outcomes & Findings for A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population (NCT NCT00356434)

Results Overview

Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

once during first 7 days of hospitalization

Results posted on

2017-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Foot Pump Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT) Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use	Sequential Compression Device Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
Overall Study STARTED	4	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foot Pump n=4 Participants Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use	Sequential Compression Device n=7 Participants Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=39 Participants	7 Participants n=41 Participants	11 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	7 Participants n=41 Participants	11 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	4 Participants n=39 Participants	7 Participants n=41 Participants	11 Participants n=35 Participants

PRIMARY outcome

Timeframe: once during first 7 days of hospitalization

Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).

Outcome measures

Outcome measures
Measure	Foot Pump n=4 Participants Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use	Sequential Compression Device n=7 Participants Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
Comfort Level	7 units on a scale Interval 5.0 to 8.0	8 units on a scale Interval 6.0 to 10.0

PRIMARY outcome

Timeframe: for 1-7 days during hospitalization

Population: Data was not collected for this outcome measure, as the study was terminated prematurely.

Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months

Population: Data was not collected for this outcome measure, as the study was terminated prematurely.

positive DVT on ultrasound

Outcome measures

Outcome data not reported

Adverse Events

Foot Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sequential Compression Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abimbola Aina

Johns Hopkins Univ

Phone: 410-955-8496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place