Trial Outcomes & Findings for Internal Jugular Vein Flow in the Sitting Position (NCT NCT02356887)

NCT ID: NCT02356887

Last Updated: 2023-01-10

Results Overview

Right Internal Jugular Vein Flow in the sitting position.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2023-01-10

Participant Flow

Participant milestones

Measure	Internal Jugular Vein Flow in the Sitting Position The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Internal Jugular Vein Flow in the Sitting Position The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Overall Study poor compliance	2

Baseline Characteristics

Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.

Baseline characteristics by cohort

Measure	Sitting Position n=12 Participants The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Age, Categorical healthy adult volunteers>18 yr · <=18 years	0 Participants n=10 Participants • Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.
Age, Categorical healthy adult volunteers>18 yr · Between 18 and 65 years	10 Participants n=10 Participants • Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.
Age, Categorical healthy adult volunteers>18 yr · >=65 years	0 Participants n=10 Participants • Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.
Sex: Female, Male Female	2 Participants n=10 Participants • Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.
Sex: Female, Male Male	8 Participants n=10 Participants • Out of 12 participants, 10 participants completed the study, two participants were excluded from the study due to poor compliance.

PRIMARY outcome

Timeframe: 1 day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Right Internal Jugular Vein Flow in the sitting position.

Outcome measures

Measure	Right IJV at Rest n=10 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=10 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Internal Jugular Venous Flow Cross-sectional area at C6	0.04 cm2 Interval 0.03 to 0.08	0.4 cm2 Interval 0.2 to 0.6
Internal Jugular Venous Flow High cross-sectional area	0.04 cm2 Interval 0.02 to 0.06	0.21 cm2 Interval 0.17 to 0.3

PRIMARY outcome

Timeframe: 1 day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

left internal jugular vein cross-sectional area in the sitting position at rest and with application of the cervical collar.

Outcome measures

Measure	Right IJV at Rest n=10 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=10 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Left Internal Jugular Vein Flow Cross-sectional area at C6	0.07 cm2 Interval 0.05 to 0.13	0.35 cm2 Interval 0.17 to 0.44
Left Internal Jugular Vein Flow High cross-sectional area	0.05 cm2 Interval 0.03 to 0.09	0.13 cm2 Interval 0.11 to 0.15

PRIMARY outcome

Timeframe: one day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Right internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar

Outcome measures

Measure	Right IJV at Rest n=12 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=12 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Right Internal Jugular Vein Flow in the Sitting Position	70 cm.sec-1 Interval 9.0 to 116.0	17 cm.sec-1 Interval 10.0 to 22.0

PRIMARY outcome

Timeframe: one day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Comparisons of right internal jugular vein flow in the sitting position at rest and with application of the cervical collar

Outcome measures

Measure	Right IJV at Rest n=10 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=10 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Right Internal Jugular Flow at C6	193 mL.min-1 Interval 50.0 to 491.0	349 mL.min-1 Interval 262.0 to 488.0
Right Internal Jugular Flow at high cross-sectional area	121 mL.min-1 Interval 23.0 to 328.0	236 mL.min-1 Interval 114.0 to 503.0

SECONDARY outcome

Timeframe: One day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Comparisons of left internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar

Outcome measures

Measure	Right IJV at Rest n=10 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=10 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Left Internal Jugular Vein Flow in the Sitting Position	30 cm.sec-1 Interval 22.0 to 47.0	12 cm.sec-1 Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: One day

Population: Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

left internal jugular vein flow in the sitting position at rest and with application of the cervical collar

Outcome measures

Measure	Right IJV at Rest n=10 Participants Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Right IJV With Collar n=10 Participants Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Left Internal flow in the Sitting Position Flow at C6	113 mL.min-1 Interval 93.0 to 323.0	183 mL.min-1 Interval 78.0 to 389.0
Left Internal flow in the Sitting Position Flow at high cross-sectional area	105 mL.min-1 Interval 38.0 to 170.0	889 mL.min-1 Interval 36.0 to 1742.0

Adverse Events

Internal Jugular Venous Flow in Sitting Position

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

Emad Al Azazi

Toronto western Hospital/UHN

Phone: 416-603-5800

Email: emad.alazazi@uhnresearch.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place