Investigative TechniquesNCT04607993
Study on the Effectiveness and Feasibility of Prone Position Ventilation Technology in Congenital Heart Disease
A study testing Prone position ventilation technique in people with Investigative Techniques, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Investigative Techniques
- What is being tested?
- Prone position ventilation technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- 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 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with lung injury after congenital heart disease or chest X-ray CT suggest that pulmonary complications need to strengthen body drainage
- Establish artificial airway, such as tracheal intubation
- Children aged 0-12 months
- Stable hemodynamics, more than 72 hours after surgery
- Informed consent of family members
Who cannot join
- Unstable hemodynamics, severe hypotension, ventricular arrhythmia
- Intracranial hypertension
- Active acute bleeding
- Spinal injuries and untreated unstable fractures, orthopedic surgery or recent abdominal surgery
- Facial trauma
- Severe pneumothorax
- Delayed chest closure and wound infection, children who need to be immobilized
Trial locations and contacts
1 site in 1 country.
China1 site
CICU, Cardiovascular Center, Childrens Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Study on the Effectiveness and Feasibility of Prone Position Ventilation Technique for Postoperative Acute Lung Injury in Infants With Congenital Heart Disease
The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. To explore the effectiveness and feasibility of prone position ventilation for children with acute lung injury after congenital heart disease surgery.
Read the detailed description
The prone position has been used to treat severe hypoxemia in patients with acute respiration dysfunction syndrome (ARDS) since the 1970s, and it has significant effectiveness in improving gas exchange. Acute lung injury (ALI) is a common complication after congenital heart disease. The clinical manifestation is refractory hypoxemia. At present, mechanical ventilation is one of the main methods for the treatment of acute lung injury-induced respiratory distress syndrome. Prone position ventilation refers to placing the patient in the prone position during mechanical ventilation to expand the lungs in the atelectasis area and improve the ratio of lung ventilation and perfusion.
Prone position ventilation technology as an important lung protection ventilation strategy has been widely used clinically at home and abroad. Compared with adults, children are more convenient and easy to implement. Due to the exact mechanism of improving oxygenation function, the current domestic and foreign development of pediatric prone ventilation technology is mainly focused on children with ARDS. There are few studies on high-quality application effects after pediatric cardiac surgery, and almost no research has been carried out, especially for pediatric heart The indications for the implementation of the prone position after the disease surgery, the specific standardized process including the position angle, the prone duration plan, etc. all need to be studied. Therefore, there is an urgent need to develop prone position ventilation technology for critically ill children with congenital heart disease after surgery to reduce postoperative pulmonary complications and shorten the time of mechanical ventilation.
- Conditions
- Investigative Techniques
- Being tested
- Prone position ventilation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position ventilation techniqueBehavioural
- Inform the children's family members of the purpose and method of prone position ventilation
- Assess the fixation of various catheters
- Suspend feeding before placing prone position
- Confirm the time to start prone position ventilation under the joint assessment of medical staff
- Place the child in a prone position with the participation of researchers, doctors and nursing staff, with the child's head tilted to one side to avoid damage to the eyes and nose due to compression, and the arms are bent upward to form a "W" . Bend both lower limbs downward to form an "M" shape, and use a soft pillow cushion to measure the knee joints to avoid compression
- The whole process ensures the smooth fixation of tracheal intubation and various catheters
- Proper sedation during prone position ventilation to achieve good human-machine synchronization
- At least 6-8 hours in prone position every day
| Study group | Role | What they receive |
|---|---|---|
| Prone position ventilation technique | Experimental | Prone position ventilation for children with congenital heart disease after surgery Receives: Behavioral: Prone position ventilation technique |
| Control group | No intervention | conventional postoperative position, no prone position ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.
Measured: at 6th hours after enrollment
Secondary outcomes (1)
Lung compliance
Lung compliance refers to the change in lung volume caused by a change in unit pressure, which represents the impact of changes in chest pressure on lung volume. It would be obtained by ventilator . It is a continuous variable. Its unit is ml/cmH2O.
Measured: at 6th hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 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 Investigative TechniquesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xu yulu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607993
- Sponsor's protocol ID
- FNF202043
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2020
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu YL, Mi YP, Zhu MX, Ren YH, Gong WJ, Fu WJ, Wang HM, Ye L, Wang Y, Zhou XY, Chen Y, Chen YY, Gu LQ, Gu Y, Jia B, Hu J, Hu XJ. Feasibility and effectiveness of prone position ventilation technique for postoperative acute lung injury in infants with congenital heart disease: study protocol for a prospective randomized study. Trials. 2021 Dec 18;22(1):929. doi: 10.1186/s13063-021-05895-1.
PubMed 34922610
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Feasibility of Prone Position Ventilation Technique for Postoperative Acute Lung Injury in Infants With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04607993
- Acronym / sponsor ID
- FNF202043
- Conditions
- Investigative Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Oct 2020 (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.
The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. To explore the effectiveness and feasibility of prone position ventilation for children with acute lung injury after congenital heart disease surgery.
Detailed description
The prone position has been used to treat severe hypoxemia in patients with acute respiration dysfunction syndrome (ARDS) since the 1970s, and it has significant effectiveness in improving gas exchange. Acute lung injury (ALI) is a common complication after congenital heart disease. The clinical manifestation is refractory hypoxemia. At present, mechanical ventilation is one of the main methods for the treatment of acute lung injury-induced respiratory distress syndrome. Prone position ventilation refers to placing the patient in the prone position during mechanical ventilation to expand the lungs in the atelectasis area and improve the ratio of lung ventilation and perfusion.
Prone position ventilation technology as an important lung protection ventilation strategy has been widely used clinically at home and abroad. Compared with adults, children are more convenient and easy to implement. Due to the exact mechanism of improving oxygenation function, the current domestic and foreign development of pediatric prone ventilation technology is mainly focused on children with ARDS. There are few studies on high-quality application effects after pediatric cardiac surgery, and almost no research has been carried out, especially for pediatric heart The indications for the implementation of the prone position after the disease surgery, the specific standardized process including the position angle, the prone duration plan, etc. all need to be studied. Therefore, there is an urgent need to develop prone position ventilation technology for critically ill children with congenital heart disease after surgery to reduce postoperative pulmonary complications and shorten the time of mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position ventilation technique | Experimental | Behavioral: Prone position ventilation techniqueProne position ventilation for children with congenital heart disease after surgery |
| Control group | No intervention | –conventional postoperative position, no prone position ventilation |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with lung injury after congenital heart disease or chest X-ray CT suggest that pulmonary complications need to strengthen body drainage
- Establish artificial airway, such as tracheal intubation
- Children aged 0-12 months
- Stable hemodynamics, more than 72 hours after surgery
- Informed consent of family members
Key exclusion criteria (7 listed)
- Unstable hemodynamics, severe hypotension, ventricular arrhythmia
- Intracranial hypertension
- Active acute bleeding
- Spinal injuries and untreated unstable fractures, orthopedic surgery or recent abdominal surgery
- Facial trauma
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 |
|---|---|---|
| Prone position ventilation technique1. Inform the children's family members of the purpose and method of prone position ventilation 2. Assess the fixation of various catheters 3. Suspend feeding before placing prone position 4. Confirm the time to start prone position ventilation under the joint assessment of medical staff 5. Place the child in a prone position with the participation of researchers, doctors and nursing staff, with the child's head tilted to one side to avoid damage to the eyes and nose due to compression, and the arms are bent upward to form a "W" . Bend both lower limbs downward to form an "M" shape, and use a soft pillow cushion to measure the knee joints to avoid compression 6. The whole process ensures the smooth fixation of tracheal intubation and various catheters 7. Proper sedation during prone position ventilation to achieve good human-machine synchronization 8. At least 6-8 hours in prone position every day | Behavioural | Prone position ventilation technique |
Primary outcome
Oxygenation index
Time frame: at 6th hours after enrollment
Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.
1 secondary outcome
Lung compliance
Time frame: at 6th hours after enrollment
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 5 Dec 2022.
- Derived from this study: PubMed 34922610Xu YL, Mi YP, Zhu MX, Ren YH, Gong WJ, Fu WJ, Wang HM, Ye L, Wang Y, Zhou XY, Chen Y, Chen YY, Gu LQ, Gu Y, Jia B, Hu J, Hu XJ. Feasibility and effectiveness of prone position ventilation technique for postoperative acute lung injury in infants with congenital heart disease: study protocol for a prospective randomized study. Trials. 2021 Dec 18;22(1):929. doi: 10.1186/s13063-021-05895-1.
- Individual participant dataSharing planned: No
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.
xu yulu principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position ventilation technique in people with Investigative Techniques, run by Children's Hospital of Fudan University 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 5 inclusion and 7 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 5 Dec 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?
Oxygenation index (time frame: at 6th hours after enrollment). 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 NCT04607993, 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 5 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.