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

Comparison of Right Ventricular Outflow Tract Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing Tetralogy of Fallot Repair

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03234582
Enrollment
20
Registered
2017-07-31
Start date
2017-07-01
Completion date
2018-08-31
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot

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

Detailed description

After completion of the TOF repair and rewarming to normothermia, all the patients will be assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF repair. In addition, velocity time integral (VTI) across left ventricular outflow tract (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP, MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on this new concentration for 5 minutes while maintaining systemic pressure within a range of 5% of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these measurements by adequate minute ventilation. Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at discharge from ICU and after 1 month of surgery on first follow-up. RV functions on echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion) and fractional RV area change during systole. The duration of post-operative mechanical ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and any morbidity or adverse outcome during hospital stay will be noted.

Interventions

None listed

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 16 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair15 minutesThe primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths

Secondary

MeasureTime frameDescription
Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair1 monthTo follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes use post-operatively by vasoactive-inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow-up

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026