Pulmonary ComplicationNCT02680925
Lung Protective Ventilation During Pulmonary Lobectomy in Children
A study testing lung protective ventilation and Conventional ventilation in people with Pulmonary Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pulmonary Complication
- What is being tested?
- lung protective ventilation and Conventional ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Feb 2018
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are scheduled for lung lobectomy under general anesthesia
- ASA physical status I, II
Who cannot join
- History of airway or pulmonary interstitial disease
- Active URI
- Systemic inflammatory response disease
- cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.
- Conditions
- Pulmonary Complication
- Being tested
- lung protective ventilation, Conventional ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung protective ventilationProcedure or surgery
TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O
Conventional ventilationProcedure or surgery
TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation group | Placebo comparator | Mechanical ventilation is maintained with tidal volume (TV) of 10 ml/kg without PEEP during two-lung ventilation and TV of 8 ml/kg without PEEP during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. Receives: Procedure: Conventional ventilation |
| Lung protective ventilation group | Active comparator | Mechanical ventilation is maintained with tidal volume (TV) of 6 ml/kg with PEEP 6 cmH2O during two-lung ventilation and TV of 4 ml/kg PEEP 6 cmH2O during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. Receives: Procedure: lung protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with pulmonary complication
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism
Measured: up to postoperative 7 days
Secondary outcomes (4)
The number of patients with desaturation
The number of patients with desaturation (SpO2 < 90%)
Measured: During surgery
The number of patients with extrapulmonary complication
Measured: through study completion, an average of 1 year
Mean duration of mechanical ventilation
Measured: through study completion, an average of 1 year
Mean duration of ICU stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
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 ComplicationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680925
- Sponsor's protocol ID
- H1511-124-725
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.
PubMed 30916035
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02680925
- Acronym / sponsor ID
- H1511-124-725
- Conditions
- Pulmonary Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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 investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation group | Placebo comparator | Procedure: Conventional ventilationMechanical ventilation is maintained with tidal volume (TV) of 10 ml/kg without PEEP during two-lung ventilation and TV of 8 ml/kg without PEEP during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. |
| Lung protective ventilation group | Active comparator | Procedure: lung protective ventilationMechanical ventilation is maintained with tidal volume (TV) of 6 ml/kg with PEEP 6 cmH2O during two-lung ventilation and TV of 4 ml/kg PEEP 6 cmH2O during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who are scheduled for lung lobectomy under general anesthesia
- ASA physical status I, II
Key exclusion criteria (4 listed)
- History of airway or pulmonary interstitial disease
- Active URI
- Systemic inflammatory response disease
- cardiac disease
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 |
|---|---|---|
| lung protective ventilationTV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O | Procedure or surgery | Lung protective ventilation group |
| Conventional ventilationTV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP | Procedure or surgery | Conventional ventilation group |
Primary outcome
The number of patients with pulmonary complication
Time frame: up to postoperative 7 days
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism
4 secondary outcomes
The number of patients with desaturation
Time frame: During surgery
The number of patients with extrapulmonary complication
Time frame: through study completion, an average of 1 year
Mean duration of mechanical ventilation
Time frame: through study completion, an average of 1 year
Mean duration of ICU stay
Time frame: through study completion, an average of 1 year
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 7 Mar 2018.
- Derived from this study: PubMed 30916035Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.
- 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.
Jin-Tae Kim, PhD 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 lung protective ventilation and Conventional ventilation in people with Pulmonary Complication, 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 2 inclusion and 4 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 7 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
The number of patients with pulmonary complication (time frame: up to postoperative 7 days). 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 NCT02680925, 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 7 Mar 2018.