Relation Between Mean Pulmonary Artery Pressure and Pulmonary Acceleration Time and Comparison With Previous Formulae

NCT ID: NCT03013062

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-30

Brief 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 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.

Conditions

Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

Exclusion Criteria

• Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ganesh Kumar Munirathinam

Fellow resident, Department of anesthesia and intensive care, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GANESH KUMAR M

Role: PRINCIPAL_INVESTIGATOR

PGIMER, CHANDIGARH

Locations

PGIMER

Chandigarh, , India

Site Status: RECRUITING

Countries

India

Central Contacts

GANESH KUMAR M, MD

Role: CONTACT

mganeshkumar19@gmail.com

8968170779

Facility Contacts

GANESH KUMAR M, MD

Role: primary

mganeshkumar19@gmail.com

8968170779

Other Identifiers

INT/IEC/2016/2641

Identifier Type: -

Identifier Source: org_study_id