Trial Outcomes & Findings for Is There Any Correlation Between Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava? (NCT NCT04173741)
NCT ID: NCT04173741
Last Updated: 2020-08-31
Results Overview
Because of the medium-high interrater correlation between USG measurements of the physicians, statistical analysis were done with the mean of USG measurements of 3 doctors.
Recruitment status
COMPLETED
Target enrollment
46 participants
Primary outcome timeframe
through study completion, 3 days
Results posted on
2020-08-31
Participant Flow
Participant milestones
| Measure |
Leg Rise Position - 3 Minutes
Patients who stayed in passive leg rise position for 3 minutes
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
Leg Rise Position - 1 Minute
Patients who stayed in passive leg rise position for 1 minute
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Leg Rise Position - 3 Minutes
Patients who stayed in passive leg rise position for 3 minutes
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
Leg Rise Position - 1 Minute
Patients who stayed in passive leg rise position for 1 minute
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
|---|---|---|
|
Overall Study
IVC measurement cannot be done
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=22 Participants
Patients who stayed in passive leg rise position for 3 minutes
USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
Group B
n=22 Participants
Patients who stayed in passive leg rise position for 1 minute
USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=22 Participants
|
74 years
n=22 Participants
|
71 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=22 Participants
|
11 Participants
n=22 Participants
|
23 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=22 Participants
|
11 Participants
n=22 Participants
|
21 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: through study completion, 3 daysBecause of the medium-high interrater correlation between USG measurements of the physicians, statistical analysis were done with the mean of USG measurements of 3 doctors.
Outcome measures
| Measure |
Leg Rise Position - 3 Minutes
n=22 Participants
Patients who stayed in passive leg rise position for 3 minutes
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. Internal jugular vein (IJV) visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
Leg Rise Position - 1 Minute
n=22 Participants
Patients who stayed in passive leg rise position for 1 minute
Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. Internal jugular vein (IJV) visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
|
|---|---|---|
|
Ultrasonography (USG) Measurements
Maximum diameter of IVC in supine position
|
1.80 centimeter
Interval 0.98 to 2.53
|
1.97 centimeter
Interval 1.26 to 2.6
|
|
Ultrasonography (USG) Measurements
Minimum diameter of IVC in supine position
|
1.22 centimeter
Interval 0.14 to 2.14
|
1.61 centimeter
Interval 0.33 to 2.32
|
|
Ultrasonography (USG) Measurements
Maximum diameter of IVC after passive leg raise
|
1.75 centimeter
Interval 0.84 to 2.83
|
2.13 centimeter
Interval 1.26 to 2.88
|
|
Ultrasonography (USG) Measurements
Minimum diameter of IVC after passive leg raise
|
1.33 centimeter
Interval 0.26 to 2.52
|
1.67 centimeter
Interval 0.44 to 2.51
|
|
Ultrasonography (USG) Measurements
Maximum diameter of IJV in supine position
|
1.03 centimeter
Interval 0.51 to 1.54
|
1.06 centimeter
Interval 0.45 to 1.52
|
|
Ultrasonography (USG) Measurements
Minimum diameter of IJV in supine position
|
0.91 centimeter
Interval 0.27 to 1.41
|
0.89 centimeter
Interval 0.31 to 1.29
|
|
Ultrasonography (USG) Measurements
Maximum diameter of IJV after passive leg raise
|
1.08 centimeter
Interval 0.47 to 1.52
|
1.00 centimeter
Interval 0.42 to 1.64
|
|
Ultrasonography (USG) Measurements
Minimum diameter of IJV after passive leg raise
|
0.90 centimeter
Interval 0.41 to 1.47
|
0.85 centimeter
Interval 0.33 to 1.28
|
Adverse Events
Leg Rise Position - 3 Minutes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Leg Rise Position - 1 Minute
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place