Effect of Mechanical Ventilation on Lung Development of Alveolar Stage
Conditions: Mechanical Ventilation, Abnormal Lung Development
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 
 
 
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                                   Research Protocol 
 
 
 
 
 
 
TITLE: Effect of Mechanical Ventilation on Lung Development of Alveolar Stage 
 
 
PROTOCOL ID: XH-21-12 
 
 
 
NCT number: / 
 
 
 
SPONSOR: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 
 
 
 
 
INVESTIGATOR: Chufan Xu 
 
 
 
Date April 27, 2021 
 
 

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 
 
 
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1. Patients recruitment 
Research protocol was approved by Xinhua Hospital Ethics Committee Affiliated to 
Shanghai Jiao Tong University School of Medicine. With written informed consents given 
by guardians of retinoblastoma (Rb) patients who undergo transcatheter intracranial 
vascular embolization (TIVE), patient characteristics, surgery information and mechanical 
ventilation (MV) indices will be collected. 
Inclusion Criteria is shown as follow: 
 
  - Age 0~3; 
  - History of full-term birth; 
  - Normal physical development in height and weight; 
  - Supine position during operation; 
Participating subjects with any one of criteria shown as follow will be excluded: 
  - Congenital pulmonary dysplasia; 
  - Current or previous lung disease; 
  - Chest deformity; 
  - Additional interference to pulmonary breathing except MV during data collection; 
  - being involved in other clinical subjects. 
 
2. Mechanical ventilation and data collection 
After induction of anesthesia, Rb patients will be transorally intubated and 
mechanically ventilated. The inspiratory time, ventilation rate, positive end-expiratory 
pressure, and oxygen concentration will be set consistently among patients. When 
anesthesiologist switches the peak ventilating pressure (PIP) around a reasonable range, 
indices including tidal volume, lung compliance, mean airway pressure on ventilator screen 
will change and be record when stable. All the ventilator setting parameters will be set 
according to the guidance of mechanical ventilation in neonates and children 
(https://doi.org/10.1007/978-3-030-83738-9_8). All the anesthesia and ventilation 
performance will be conducted by a fully qualified senior anesthesiologist to assure 
standardized anesthesia, ventilation and operation procedure. Data that this research plan 

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 
 
 
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to collect can be divided into 3 categories,  
• 
Patient characteristics, including age in days, gender, height and weight; 
• 
Surgery information, including total number of operation and date of each operation, 
• 
Mechanical ventilation information, including ventilation duration, tidal volume (Vt), 
lung compliance, mean airway pressure (MAP) and peak pressure (PIP). 
 
3.  Statistical analysis 
 
The respective contribution of PIP, operation number, age and body mass index (BMI) 
to Vt per BMI, pulmonary compliance and MAP will be quantified as estimate with their 
significance (showed as p value), which can be obtained by regression analysis through 
statistical software SPSS Statistics. P < 0.05 is considered as statistically significant criteria.