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Patient After Cardiac Valve SurgeryNCT05500495

The Association Between Intestinal Perfusion and Prolonged Mechanical Ventilation in Patients After Cardiac Valve Surgery

An observational study of Patient After Cardiac Valve Surgery and Patient With Prolonged Mechanical Ventilation, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
100 participants
Where
1 siteChina
Study dates
1 Jan 2021to 1 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 1) 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.

Who cannot join

  • 1) 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking union medical college hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: The Association Between Doppler Parameters of Superior Mesenteric Artery(SMA) and Prolonged Mechanical Ventilation(PMV) in Patients After Cardiac Valve Surgery

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.

Read the detailed description

Patient enrollment This prospective observational study was performed in the 15-bed adult critical care unit in Adult General Hospital from January 2021 to March 2022.

The inclusion criteria were as follows: 1) 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.

The exclusion criteria were as follows: 1) 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 >3, 3) hepatic dysfunction or liver cirrhosis, portal hypertension, 4) cancer or end-stage renal diseases, 5) poor quality of abdominal ultrasound images.

Doppler ultrasound monitoring Doppler ultrasound was performed with an ultrasound system consisting of a 2-5 MHz C60xp Probe (X-Porte Ultrasound System, FUJIFILM SONOSITE, INC., USA). Blood flow parameters were measured by two physicians, each physician measured twice and averaged, and then averaged the two results. Each of the two ICU physicians had more than four years of experience in critical ultrasound and obtained certification from the Chinese Critical Ultrasound Study Group. Two skilled physicians conducted a total of 40 measurements on ten patients after cardiac valve surgery to evaluate inter-observer reproducibility.

The SMA flow was measured 1 cm proximal to the abdominal aorta. The angle of insonation was < 60°. The time-velocity waveform readings were used to measure the peak systolic velocity (PSV), end-diastolic velocity(EDV), resistance index(RI), time-averaged mean velocity(TAMV), pulsatility index (PI), according to the calculation software carried by the ultrasound. PI=(PSV-EDV)/TAMV, and RI=(PSV-EDV)/PSV.

Data collection Demographic information was recorded for further analyses (e.g., age, gender, EuroSCORE-II, sequential organ failure assessment (SOFA) score, body mass index (BMI), and hemodynamic parameters and blood gas analysis data). In addition, types of operation and operation time were collected. Moreover, outcome variables (e.g., hospital mortality, time of MV, length of ICU stay) were recorded for further comparison.

Statistical analysis The median plus the interquartile range (IQR) or mean standard deviation is used to show demographic data. The Shapiro-Wilk test was used to evaluate normality. The differences between groups were compared using the student's t-test for continuous variables with normality distribution and the Mann-Whitney U test for those without normality distribution. The differences between groups for categorical variables were compared by performing a Chi-square test. Correlations between variables and PMV were assessed by conducting logistic regression analysis. Variables showing statistical significance in the univariate logistic regression were selected covered in the multivariate logistic regression. Furthermore, to evaluate the predictive ability of the variables for PMV, a receiver operating characteristic (ROC) curve was applied. Statistical significance was set at P < 0.05. All analyzed P-values were two-sided. Statistical analyses were performed using the SPSS 25.0 software package (SPSS, Chicago). Bland-Altman plots with the mean difference and 95 percent limit of agreement (LOA) were used to assess inter-observer agreement, and statistical analyses were done using MedCalc Statistical software.

Being tested
no intervention
Keywords
Pulsatility index of the superior mesenteric artery; Prolonged Mechanical Ventilation; cardiac valve surgery; intestinal perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

Study groups in NCT05500495
Study groupRoleWhat they receive
prolonged mechanical ventilation grouppatients had 96 hours or more (PMV group).
Receives: Other: no intervention
control grouppatients had less than 96 hours of mechanical ventilation (control group)
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hours of mechanical ventilation

    hours of mechanical ventilation

    Measured: within 30mins at ICU admission

Secondary outcomes (1)
  1. ICU residence time

    ICU residence time

    Measured: within 30mins at ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05500495
Sponsor's protocol ID
ZS-3088
Status last verified
Aug 2022
First submitted
11 Aug 2022
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Patient After Cardiac Valve Surgery and Patient With Prolonged Mechanical Ventilation, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hours of mechanical ventilation (time frame: within 30mins at ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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