Pulmonary HypertensionNCT03013062
Relation Between Mean Pulmonary Artery Pressure and Pulmonary Acceleration Time and Comparison With Previous Formulae
An observational study of Pulmonary Hypertension, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2017to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: > 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure
Who may be able to join
- 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure
Who cannot join
- Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, 160012
GANESH KUMAR M, MD, 8968170779, mganeshkumar19@gmail.com
About this study
Official title: Derivation of New Formula Relating Pulmonary Acceleration Time and Mean Pulmonary Artery Pressure in Indian Population and Comparison With Previous Formulas
Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the three formulae
Read the detailed description
After obtaining ethics committee approval and informed patient consent, minimum 25 patients > 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure will be enrolled in this study.The demographics and the preoperative echocardiographic measurement will be noted. In the operating room, once the intravenous access is obtained, central venous catheterisation and pulmonary artery catheterisation will be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is performed patient will be induced with opioids, intravenous or inhalational agents, and muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed before and after bypass, which is routine in all patients undergoing cardiac surgery in the institution. Echocardiographic images will be analysed by two separate echocardiographers to detect inter-individual variability. Patient blood pressure and heart rate will be maintained within 20% of their baseline value throughout surgery. Based on the patient condition at the end of surgery, extubation will be done in the operating room or in intensive care unit (ICU) after a period of elective ventilation.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| WITH PULMONARY HYPERTENSION | It is defined as MPAP > 25 mm Hg at rest or >30 mm Hg during exercise with PVR > 3 wood units and PCWP < 15 mm Hg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary acceleration time
Measured: Till post-extubation, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganesh Kumar Munirathinam, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- GANESH KUMAR M, Principal investigator, PGIMER, CHANDIGARH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013062
- Sponsor's protocol ID
- INT/IEC/2016/2641
- Status last verified
- Jun 2017
- First submitted
- 2 Jan 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of New Formula Relating Pulmonary Acceleration Time and Mean Pulmonary Artery Pressure in Indian Population and Comparison With Previous Formulas
- ClinicalTrials.gov ID
- NCT03013062
- Acronym / sponsor ID
- INT/IEC/2016/2641
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the three formulae
Detailed description
After obtaining ethics committee approval and informed patient consent, minimum 25 patients > 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure will be enrolled in this study.The demographics and the preoperative echocardiographic measurement will be noted. In the operating room, once the intravenous access is obtained, central venous catheterisation and pulmonary artery catheterisation will be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is performed patient will be induced with opioids, intravenous or inhalational agents, and muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed before and after bypass, which is routine in all patients undergoing cardiac surgery in the institution. Echocardiographic images will be analysed by two separate echocardiographers to detect inter-individual variability. Patient blood pressure and heart rate will be maintained within 20% of their baseline value throughout surgery. Based on the patient condition at the end of surgery, extubation will be done in the operating room or in intensive care unit (ICU) after a period of elective ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WITH PULMONARY HYPERTENSION | – | –It is defined as MPAP > 25 mm Hg at rest or >30 mm Hg during exercise with PVR > 3 wood units and PCWP < 15 mm Hg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- > 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure
Key inclusion criteria (1 listed)
- 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure
Key exclusion criteria (1 listed)
- Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary acceleration time
Time frame: Till post-extubation, an average of 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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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.
GANESH KUMAR M principal investigator
PGIMER, CHANDIGARH
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 Pulmonary Hypertension, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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: status not confirmed, as of the sponsor's last update on 2 Jun 2017. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GANESH KUMAR M, MD (8968170779, mganeshkumar19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary acceleration time (time frame: Till post-extubation, an average of 2 days). 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 2 Jun 2017.