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.
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
- Conditions the study is for
- Patient After Cardiac Valve Surgery, Patient With Prolonged Mechanical Ventilation
- 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
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 group | Role | What they receive |
|---|---|---|
| prolonged mechanical ventilation group | patients had 96 hours or more (PMV group). Receives: Other: no intervention | |
| control group | patients 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.
hours of mechanical ventilation
hours of mechanical ventilation
Measured: within 30mins at ICU admission
Secondary outcomes (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.
- First posted15 Aug 2022
- Study start1 Jan 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient After Cardiac Valve SurgeryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Doppler Parameters of Superior Mesenteric Artery(SMA) and Prolonged Mechanical Ventilation(PMV) in Patients After Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT05500495
- Acronym / sponsor ID
- ZS-3088
- Keywords
- Pulsatility index of the superior mesenteric artery; Prolonged Mechanical Ventilation; cardiac valve surgery; intestinal perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolonged mechanical ventilation group | – | Other: no interventionpatients had 96 hours or more (PMV group). |
| control group | – | Other: no interventionpatients had less than 96 hours of mechanical ventilation (control group) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient was enrolled in the 15-bed adult critical care unit in Adult General Hospital
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | control group, prolonged mechanical ventilation group |
Primary outcome
hours of mechanical ventilation
Time frame: within 30mins at ICU admission
hours of mechanical ventilation
1 secondary outcome
ICU residence time
Time frame: within 30mins at ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.