NCT05498922

Effect of Mechanical Ventilation on Lung Development of Alveolar Stage

Completed Last updated 12 August 2022

What this trial tests

trial testing Peak pressure when mechanical ventilation was switched around a reasonable range in Mechanical Ventilation in 100 participants. Completed in 31 May 2022.

Timeline

27 April 2021

Primary endpoint
31 March 2022

31 May 2022

Quick facts

Lead sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	27 April 2021
Primary completion	31 March 2022
Estimated completion	31 May 2022
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Abnormal Lung Development — all drugs for Abnormal Lung Development →

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Under 3, any sex, with Mechanical Ventilation or Abnormal Lung Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.