Mechanical VentilationNCT05498922
Effect of Mechanical Ventilation on Lung Development of Alveolar Stage
An observational study of Mechanical Ventilation and Abnormal Lung Development, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Mechanical Ventilation, Abnormal Lung Development
- What is being tested?
- Peak pressure when mechanical ventilation was switched around a reasonable range
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age 0~3;
- History of full-term birth;
- Normal physical development in height and weight;
- Supine position during operation;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia, Shanghai Xinhua hospital
Shanghai, Shanghai Municipality, 200082
About this study
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.
Read more
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.
Read the detailed description
Human lung development begins in the early stage of intrauterine pregnancy, approximately 4-7 post-conception weeks (pcw), and lasts until 3 years after birth. It can be divided into five morphological stages, namely embryonic stage, pseudoglandular stage, canalicular stage, saccular stage and alveolar stage. Alveolar stage is the process of alveolar formation during which distal saccules subdivide into alveoli and fuse into capillary until completely surround it, contributing to the rapid increase of gas exchange surface. Alveolar stage spans from 36 pcw to 3 years of age, and thus could be influenced by external factors.
Mechanical ventilation (MV) is not only an important rescue method for critically ill children with respiratory distress, but also an indispensable respiratory support method for young children during pediatric surgeries. Different from spontaneous breathing which creates negative pressure in chest to bring in air, ventilators expand alveoli by pushing gas into lung with positive pressure. Therefore, no matter how ventilator nowadays has been optimized to provide breathing movement close to the natural breathing, it still acts against physiological characteristics and has been reported to cause ventilator-induced lung injury when giving respiratory support to both pediatric and adult patients in intensive care unit. However, for children under the age of 3 with healthy pulmonary system, whether and how MV affects the alveolar stage of 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.
Retinoblastoma (Rb) is a rare form of cancer that rapidly develops from the immature cells of a retina, the light-detecting tissue of the eye. It is the most common malignant cancer of the eye in children, and it is almost exclusively found in young children. Transcatheter intracranial vascular embolization (TIVE) is one of the main treatments for Rb, and to assure the smooth operation in pediatric children for their poor medical compliance, general anesthesia and MV are compulsory during TIVE. Given TIVE is usually performed time and time again to help attenuating cancer growth and delaying the diseased eye removal, we can infer the influence of MV on infant lung development by analyzing the contribution of MV operation number, which is also the TIVE operation times, to respiratory indices, with the premise that TIVE operation duration is nearly equal when it is operated by same clinical group.
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 Rb patients under the age of 3, when undergoing TIVE. 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 under setting parameters recommended by the guidance of mechanical ventilation in neonates and children (https://doi.org/10.1007/978-3-030-83738-9_8).
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.
- Conditions
- Mechanical Ventilation, Abnormal Lung Development
- Being tested
- Peak pressure when mechanical ventilation was switched around a reasonable range
- Keywords
- Mechanical ventilation, Infant lung development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak pressure when mechanical ventilation was switched around a reasonable rangeProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start27 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lai Wang, Chief doctor, Principal investigator, Department of Anesthesia, Shanghai Xinhua hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498922
- Sponsor's protocol ID
- XH-21-12
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Ventilation on Lung Development of Alveolar Stage
- ClinicalTrials.gov ID
- NCT05498922
- Acronym / sponsor ID
- XH-21-12
- Conditions
- Mechanical Ventilation, Abnormal Lung Development
- Keywords
- Mechanical ventilation, Infant lung development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human lung development begins in the early stage of intrauterine pregnancy, approximately 4-7 post-conception weeks (pcw), and lasts until 3 years after birth. It can be divided into five morphological stages, namely embryonic stage, pseudoglandular stage, canalicular stage, saccular stage and alveolar stage. Alveolar stage is the process of alveolar formation during which distal saccules subdivide into alveoli and fuse into capillary until completely surround it, contributing to the rapid increase of gas exchange surface. Alveolar stage spans from 36 pcw to 3 years of age, and thus could be influenced by external factors.
Mechanical ventilation (MV) is not only an important rescue method for critically ill children with respiratory distress, but also an indispensable respiratory support method for young children during pediatric surgeries. Different from spontaneous breathing which creates negative pressure in chest to bring in air, ventilators expand alveoli by pushing gas into lung with positive pressure. Therefore, no matter how ventilator nowadays has been optimized to provide breathing movement close to the natural breathing, it still acts against physiological characteristics and has been reported to cause ventilator-induced lung injury when giving respiratory support to both pediatric and adult patients in intensive care unit. However, for children under the age of 3 with healthy pulmonary system, whether and how MV affects the alveolar stage of 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.
Retinoblastoma (Rb) is a rare form of cancer that rapidly develops from the immature cells of a retina, the light-detecting tissue of the eye. It is the most common malignant cancer of the eye in children, and it is almost exclusively found in young children. Transcatheter intracranial vascular embolization (TIVE) is one of the main treatments for Rb, and to assure the smooth operation in pediatric children for their poor medical compliance, general anesthesia and MV are compulsory during TIVE. Given TIVE is usually performed time and time again to help attenuating cancer growth and delaying the diseased eye removal, we can infer the influence of MV on infant lung development by analyzing the contribution of MV operation number, which is also the TIVE operation times, to respiratory indices, with the premise that TIVE operation duration is nearly equal when it is operated by same clinical group.
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 Rb patients under the age of 3, when undergoing TIVE. 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 under setting parameters recommended by the guidance of mechanical ventilation in neonates and children (https://doi.org/10.1007/978-3-030-83738-9_8).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Age 0~3;
- History of full-term birth;
- Normal physical development in height and weight;
- Supine position during operation;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peak pressure when mechanical ventilation was switched around a reasonable rangeThe 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. | Procedure or surgery | – |
Primary outcome
Tidal Volume (Vt)
Time frame: an average of 5 minutes
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)
Pulmonary compliance
Time frame: an average of 5 minutes
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.
Mean airway pressure (MAP)
Time frame: an average of 5 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- BackgroundFernandes 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
- guidance of mechanical ventilation in neonates and childrenLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lai Wang, Chief doctor principal investigator
Department of Anesthesia, Shanghai Xinhua hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Abnormal Lung Development, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal Volume (Vt) (time frame: an average of 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05498922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.