Pulmonary Atelectasis, PostoperativeNCT03486847
Postoperative Atelectasis in Pediatric Patients With Prone Position
A study testing Repetitive recruitment with PEEP and One recruitment with PEEP in people with Pulmonary Atelectasis, Postoperative and Atelectasis, Compression, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age < 3 years. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Pulmonary Atelectasis, Postoperative, Atelectasis, Compression
- What is being tested?
- Repetitive recruitment with PEEP and One recruitment with PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2018to 31 Jul 2019
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing general anesthesia with prone position
- Endotracheal intubation and mechanical ventilation during general anesthesia
- Operation time is more than 2 hours
Who cannot join
- Previous lung surgery
- Any abnormal findings such as atelectasis, pneumothorax, pleural effusion, or pneumonia on preoperative chest X-ray
- Researchers judge (to be inappropriate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Atelectasis in Pediatric Patients With Prone Position : Effect of Repetitive Alveolar Recruitment by Lung Ultrasound
This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age < 3 years.
Read the detailed description
Atelectasis is common in pediatric patients after general anesthesia. Particularly, infants are more likely to develop atelectasis or ventilation-perfusion imbalance after general anesthesia because of the immature ribs and respiratory muscles, the high compliance of the rib cage and a significant reduction in functional residual capacity (FRC) during general anesthesia. Previous studies have reported that alveolar recruitment and positive end-expiratory pressure (PEEP) can be used to reduce atelectasis in children. Also, previous studies have shown that the lung ultrasound can be used to evaluate the degree of atelectasis during general anesthesia in children.
However, none of the previous studies investigated the incidence of atelectasis, the effect of alveolar recruitment, and the PEEP in pediatric patients under general anesthesia with prone position. The purpose of this study was to evaluate previously described parameters using lung ultrasound.
- Being tested
- Repetitive recruitment with PEEP, One recruitment with PEEP
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive recruitment with PEEPProcedure or surgery
Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before suegery and once an hour during surgery. PEEP is set to 7 cmH2O.
One recruitment with PEEPProcedure or surgery
Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive recruitment with PEEP | Experimental | One alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery Receives: Procedure: Repetitive recruitment with PEEP |
| One recruitment with PEEP | Active comparator | One alveolar recruitment at before surgery Receives: Procedure: One recruitment with PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pre-extubation atelectasis
Incidence of pre-extubation atelectasis accessed by lung ultrasound
Measured: postoperative 10 minutes
Secondary outcomes (4)
Incidence of intraoperative atelectasis after intubation
Incidence of intraoperative atelectasis after induction accessed by lung ultrasound
Measured: intraoperative
Incidence of intraoperative atelectasis after position change to prone
Incidence of intraoperative atelectasis after position change to prone accessed by lung ultrasound
Measured: intraoperative
Incidence of intraoperative and postoperative (within 12hr) desaturation
Oxygen saturation by pulse oximetry (SpO2) ≤ 95% or 10% below the baseline value
Measured: intraoperative and postoperative (within 12hr)
Incidence of intraoperative hypotension
Systolic blood pressure (SBP) ≤ 20% below the baseline value
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start29 Mar 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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 Pulmonary Atelectasis, PostoperativeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee Kim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486847
- Sponsor's protocol ID
- H-1802-088-923
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jang YE, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS. Effect of regular alveolar recruitment on intraoperative atelectasis in paediatric patients ventilated in the prone position: a randomised controlled trial. Br J Anaesth. 2020 May;124(5):648-655. doi: 10.1016/j.bja.2020.01.022. Epub 2020 Mar 10.
PubMed 32169254
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Atelectasis in Pediatric Patients With Prone Position : Effect of Repetitive Alveolar Recruitment by Lung Ultrasound
- ClinicalTrials.gov ID
- NCT03486847
- Acronym / sponsor ID
- H-1802-088-923
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Apr 2018 (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.
This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age < 3 years.
Detailed description
Atelectasis is common in pediatric patients after general anesthesia. Particularly, infants are more likely to develop atelectasis or ventilation-perfusion imbalance after general anesthesia because of the immature ribs and respiratory muscles, the high compliance of the rib cage and a significant reduction in functional residual capacity (FRC) during general anesthesia. Previous studies have reported that alveolar recruitment and positive end-expiratory pressure (PEEP) can be used to reduce atelectasis in children. Also, previous studies have shown that the lung ultrasound can be used to evaluate the degree of atelectasis during general anesthesia in children.
However, none of the previous studies investigated the incidence of atelectasis, the effect of alveolar recruitment, and the PEEP in pediatric patients under general anesthesia with prone position. The purpose of this study was to evaluate previously described parameters using lung ultrasound.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive recruitment with PEEP | Experimental | Procedure: Repetitive recruitment with PEEPOne alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery |
| One recruitment with PEEP | Active comparator | Procedure: One recruitment with PEEPOne alveolar recruitment at before surgery |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing general anesthesia with prone position
- Endotracheal intubation and mechanical ventilation during general anesthesia
- Operation time is more than 2 hours
Key exclusion criteria (3 listed)
- Previous lung surgery
- Any abnormal findings such as atelectasis, pneumothorax, pleural effusion, or pneumonia on preoperative chest X-ray
- Researchers judge (to be inappropriate)
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 |
|---|---|---|
| Repetitive recruitment with PEEPApply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before suegery and once an hour during surgery. PEEP is set to 7 cmH2O. | Procedure or surgery | Repetitive recruitment with PEEP |
| One recruitment with PEEPApply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O. | Procedure or surgery | One recruitment with PEEP |
Primary outcome
Incidence of pre-extubation atelectasis
Time frame: postoperative 10 minutes
Incidence of pre-extubation atelectasis accessed by lung ultrasound
4 secondary outcomes
Incidence of intraoperative atelectasis after intubation
Time frame: intraoperative
Incidence of intraoperative atelectasis after position change to prone
Time frame: intraoperative
Incidence of intraoperative and postoperative (within 12hr) desaturation
Time frame: intraoperative and postoperative (within 12hr)
Incidence of intraoperative hypotension
Time frame: intraoperative
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 16 Apr 2020.
- Derived from this study: PubMed 32169254Jang YE, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS. Effect of regular alveolar recruitment on intraoperative atelectasis in paediatric patients ventilated in the prone position: a randomised controlled trial. Br J Anaesth. 2020 May;124(5):648-655. doi: 10.1016/j.bja.2020.01.022. Epub 2020 Mar 10.
- Individual participant dataSharing planned: No
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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.
Hee Kim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive recruitment with PEEP and One recruitment with PEEP in people with Pulmonary Atelectasis, Postoperative and Atelectasis, Compression, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 3 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 16 Apr 2020. 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 South Korea. 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?
Incidence of pre-extubation atelectasis (time frame: postoperative 10 minutes). 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 NCT03486847, 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 16 Apr 2020.