NCT05500495

Brief Summary

Background This study aimed to confirm that alterations in Doppler parameters of superior mesenteric artery(SMA) blood flow caused by intestinal hypoperfusion are associated with prolonged mechanical ventilation(PMV) in patients after cardiac valve surgery. Methods The patients' basic hemodynamics parameters, and the SMA blood flow parameters monitored by Doppler ultrasound were collected in the supine position at admission. The length of mechanical ventilation continued to be monitored. The SMA Doppler parameters were measured again when the patient was extubated. PMV was defined as MV≥96 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 11, 2022

Last Update Submit

August 11, 2022

Conditions

Keywords

Pulsatility index of the superior mesenteric artery; Prolonged Mechanical Ventilation; cardiac valve surgery; intestinal perfusion

Outcome Measures

Primary Outcomes (1)

  • hours of mechanical ventilation

    hours of mechanical ventilation

    within 30mins at ICU admission

Secondary Outcomes (1)

  • ICU residence time

    within 30mins at ICU admission

Study Arms (2)

prolonged mechanical ventilation group

patients had 96 hours or more (PMV group).

Other: no intervention

control group

patients had less than 96 hours of mechanical ventilation (control group)

Other: no intervention

Interventions

no intervention

control groupprolonged mechanical ventilation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient was enrolled in the 15-bed adult critical care unit in Adult General Hospital

You may qualify if:

  • \) patients admitted to ICU immediately after cardiac valve surgery; 2) age 18-80 years; 3) sinus rhythm; 4) without active bleeding or pneumothorax, and 5) complete measurement data.

You may not qualify if:

  • \) history of peripheral vascular disease, 2) patients with severe stenosis defined as SMA peak systolic velocity (SMA-PSV \>275 cm/s or SMA-PSV/abdominal aorta peak velocity of \>310, 3) hepatic dysfunction or liver cirrhosis, portal hypertension, 4) cancer or end-stage renal diseases, 5) poor quality of abdominal ultrasound images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

January 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations