Skip to content

Lung protective effect of ulinastatin combined with alveolar recruitment maneuvers in children with right vertical infra-axillary thoracotomy for repair of atrioventricular septal defect

Lung protective effect of ulinastatin combined with alveolar recruitment maneuvers in children with right vertical infra-axillary thoracotomy for repair of atrioventricular septal defect

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023576
Enrollment
Unknown
Registered
2019-06-02
Start date
2019-06-03
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

Congenital heart disease

Interventions

group C:None
the ulinastatin group(group U):Patients in group U were intravenously infused with ulinastatin (Techpool, Guangdong, China) at a rate of 10,000 U/ kg/hour for the first hour after anesthesia induction
the alveolar recruitment maneuver group(ARM, group A):In group A, immediately after the end of cardiopulmonary bypass, lung recruitment was achieved by sequential increases in PEEP in three steps from
the ulinastatin combined with alveolar recruitment maneuver group(group U+A):Patients in group U+A were intravenously infused with ulinastatin and alveolar recruitment maneuver.

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) scores between class II and III pediatric patients undergoing correction of congenital heart disease whit right vertical infra-axillary thoracotomy under general anaesthesia gave written informed consent to participate in this randomized controlled study. Inclusion criteria were aged 1-6 year, and preoperative diagnosis of atrial septal defect (ASD), ventricular septal defect (VSD) and partial atrioventricular septal defects (PAVSD).

Exclusion criteria

Exclusion criteria: Exclusion criteria were refusal to give consent, BMI 35 kg/m2, significant cardiac dysfunction (left ventricular ejection fraction ,40%) , asthma requiring bronchodilator therapy, restrictive lung disease and emergency surgery.

Design outcomes

Primary

MeasureTime frame
CI;IL-2, IL-6, IL-8, IL-10 and TNF-a;respiratory index (RI);oxygenation index (OI);Mechanical ventilation time;Time of intensive care unit;Hospital stay;respiratory compliance;

Countries

China

Contacts

Public ContactJun Ma

Beijing Anzhen Hospital, Capital Medical University

junma_mazui@163.com+86 010 64456329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026