Effect of Mechanical Ventilation on Lung Development of Alveolar Stage

NCT05498922 | Completed

• 1 other identifier: XH-21-12
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Human lung development begins at about 4-7 post-conception weeks (pcw), and lasts until 3 years after birth, which can be divided into five morphological stages. Alveolar stage is the last stage during which alveoli forms, contributing to the rapid increase of gas exchange surface. Alveolar stage spans from 36 pcw to age 3, so it could be influenced by external factors. Mechanical ventilation (MV) is not only an important rescue method for children with respiratory distress, but also an indispensable respiratory support for young children during surgeries. When ventilators expand alveoli by pushing gas into lung with positive pressure, it acts against physiological characteristics and was reported to cause ventilator-induced lung injury. However, for children under the age of 3 with healthy lung, whether and how MV affects lung development has not been clearly elucidated. Pressure-controlled ventilation is the most common utilized ventilating method in neonates and infants, which adjusts peak inspiratory pressure (PIP) as needed to meet oxygenation and ventilation goal. Under same PIP, will tidal volume (Vt), mean airway pressure (MAP) be variable based largely on the patients' respiratory mechanics like lung compliance and airway resistance. Therefore, how previous MV affects the alveolar stage of lung development can be partly indicated by analyzing and comparing indices like Vt, MAP and lung compliance when collected under same ventilator settings in later MV. Approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and written informed consents obtained from all patients' guardians, this clinical research collected data from retinoblastoma patients under the age of 3, when undergoing transcatheter intracranial vascular embolization (TIVE), one of the main Rb treatments. These data 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, Vt, lung compliance, MAP and PIP. The respective contribution of PIP, operation number, age and body mass index (BMI) to Vt per BMI, pulmonary compliance and MAP were quantified as estimate with their significance (showed as p value), which were obtained by regression analysis. More details are described in Detailed Description as follow.

Conditions

Mechanical Ventilation; Abnormal Lung Development

Keywords

Mechanical ventilation; Infant lung development

Outcome Measures

Primary Outcomes (3)

• Tidal Volume (Vt)

  Vt is the quantity of gas delivered with each breath. In general, target tidal volumes in pediatrics range between 5 and 8 mL/kg of ideal body weight (IBW)

  an average of 5 minutes

• Pulmonary compliance

  pulmonary compliance is a measure of the lung's ability to stretch and expand. As an index of respiratory mechanics, it can indicate the stiffness of lung. For example, low pulmonary compliance is often seen in fibrosis.

  an average of 5 minutes

• Mean airway pressure (MAP)

  MAP typically refers to the mean pressure applied during positive-pressure mechanical ventilation. It correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma. It can also match the alveolar pressure if there is no difference between inspiratory and expiratory resistance.

  an average of 5 minutes

Interventions

Peak pressure when mechanical ventilation was switched around a reasonable range PROCEDURE

The research protocol was approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and written informed consents were obtained from all patients. After induction of anesthesia, Rb patients were transorally intubated and mechanically ventilated. The inspiratory time, ventilation rate, positive end-expiratory pressure, and oxygen concentration were set consistently among patients. When anesthesiologist switch the peak pressure around a reasonable range, indices including tidal volume, lung compliance, mean airway pressure on ventilator screen changed and were recorded when stable. All the ventilator setting parameters followed 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 were conducted by a fully qualified senior anesthesiologist to assure standardized and safe anesthesia, ventilation and operation procedure.

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All recruited pediatric subjects were patients with retinoblastoma, of which girls constituted 47.61%. The youngest of patients was 4.5 months old and the oldest was 2.6 years old.

You may qualify if:

• Age 0\~3;
• History of full-term birth;
• Normal physical development in height and weight;
• Supine position during operation;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Related Publications (1)

• Fernandes N., Chawla S. (2022) Mechanical Ventilation for Neonates. In: Sarnaik A.P., Venkataraman S.T., Kuch B.A. （eds） Mechanical Ventilation in Neonates and Children. Springer, Cham. https://doi.org/10.1007/978-3-030-83738-9_8

  BACKGROUND

Related Links

• guidance of mechanical ventilation in neonates and children

Study Officials

• Lai Wang, Chief doctor

  Department of Anesthesia, Shanghai Xinhua hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: April 27, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-04

Locations

CN (1)