Comparison of RVOT Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing TOF Repair

NCT03234582 | Unknown

• 1 other identifier: NK/3021/pH/110
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study will be to compare intraoperative post TOF repair RVOT gradient under two different anaesthetic depths. Secondary objectives will be to follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow- up

Conditions

Tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair

  The primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths

  15 minutes

Secondary Outcomes (1)

• Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair

  1 month

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.

You may qualify if:

• All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.

You may not qualify if:

• TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Nandita Kakkar

Chandigarh, 160012, India

Location

Related Publications (1)

• Toshkhani D, Arya VK, Kajal K, Thingnam SKS, Rana SS. Comparison of right ventricular outflow tract gradient under anesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair. Ann Pediatr Cardiol. 2021 Jan-Mar;14(1):18-25. doi: 10.4103/apc.APC_147_19. Epub 2020 Oct 19.

  PMID: 33679057 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dr. Dheemta Toshkhani, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 31, 2017
• Study Start: July 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 31, 2018
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

IN (1)