Effect of Mechanical Ventilation on Lung Development of Alveolar Stage

NCT05498922 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-08-12

No results posted yet for this study

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

Interventions

PROCEDURE

Peak pressure when mechanical ventilation was switched around a reasonable range

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.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Lai Wang, Chief doctor · Department of Anesthesia, Shanghai Xinhua hospita

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2022-03-31
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498922 on ClinicalTrials.gov