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The Effects of Individualized Lung-protective Ventilation With Lung Dynamic Compliance-guided Positive End-expiratory Pressure(PEEP) Titration on Postoperative Pulmonary Complications of Pediatric Video-assisted Thoracoscopic Surgery (PEEP)

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ClinicalTrials.gov Identifier: NCT05386901
Recruitment Status : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Jiaxiang Chen, Shantou University Medical College

Brief Summary:
This study evaluates the influence of individualized lung-protective ventilation strategy(LPVS) on postoperative pulmonary complications(PPCs) through a randomized controlled trial when children undergoing thoracoscopic surgery with one-lung ventilation(OLV).The investigators evaluate the impact of using lung dynamic compliance-guided Positive End-expiratory Pressure(PEEP) versus conventional PEEP on a pressure-controlled ventilation(PCV).The researchers also analyzed perioperative vital signs and respiratory indicators of these LPVS.

Condition or disease Intervention/treatment Phase
Anesthesia Surgery Procedure: Conventional positive end-expiratory pressure(PEEP) Procedure: Lung dynamic compliance guided positive end-expiratory pressure(PEEP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly assigned to lung dynamic compliance-guided individualized PEEP group and traditional PEEP group.The traditional lung protective ventilation experimental group kept PEEP at 5cmH2O, and the lung dynamic compliance-oriented individualized PEEP group passed the incremental PEEP (0-14cmH2O). lung dynamic compliance==Vt/(Pplat-PEEP).The initial PEEP is set to 0cmH2O, and the PEEP is increased by 2cmH2O every 2 minutes. Observe the PEEP value corresponding to the maximum lung dynamic compliance during the process. After the incremental PEEP process is completed, set the PEEP value for ventilation until the end of the operation.
Masking: Single (Participant)
Masking Description: This experiment adopts a single-blind scheme. Only the researcher understands the grouping situation, and the research subjects do not know whether they are the experimental group or the control group. The researcher can better observe and understand the research subjects, and can timely and appropriately deal with possible occurrences of the research subjects when necessary. Unexpected problems, so that the safety of the research object is guaranteed.
Primary Purpose: Treatment
Official Title: The Effects of Individualized Lung-protective Ventilation With Lung Dynamic Compliance-guided Positive End-expiratory Pressure(PEEP) Titration on Postoperative Pulmonary Complications of Pediatric Video-assisted Thoracoscopic Surgery
Estimated Study Start Date : June 10, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Experimental: Conventional positive end-expiratory pressure(PEEP)
Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set the PEEP value to 5 cmH2O until the end of the operation.
Procedure: Conventional positive end-expiratory pressure(PEEP)
Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to 5 cmH2O until the end of the operation.

Experimental: Lung dynamic compliance guided positive end-expiratory pressure(PEEP)
Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set initial PEEP to 0cmH2O,and the PEEP is increased by 2 cmH2O every 2 minutes.Observing the PEEP value corresponding to the maximum lung dynamic compliance during the process that lung dynamic compliance=Vt/(Pplat-PEEP).After the incremental PEEP process is completed, setting the PEEP value for ventilation until the end of the operation.
Procedure: Lung dynamic compliance guided positive end-expiratory pressure(PEEP)
Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to individual value until the end of the operation.The individualized values are obtained by observing the maximum Lung dynamic compliance during PEEP titration.




Primary Outcome Measures :
  1. Postoperative pulmonary complication(PPCs) rate at 7 days [ Time Frame: 7 days after surgery ]

    PPCs are classified into 5 grades according to Postoperative pulmonary complications score fo JAMA.

    Grade 1:Cough, dry.Microatelectasis.Dyspnea, not due to other documented cause

    Grade 2:Cough, productive, not due to other documented cause.Bronchospasm.Hypoxemia (SpO2 ≤ 90%) at room air.Atelectasis.Hypercarbia (PaCO2 > 50 mmHg), requiring treatment

    Grade 3:Pleural effusion, resulting in thoracentesis.Pneumonia.Pneumothorax.Noninvasive ventilation, strictly applied to those with all of the following: a) oxygen saturation(SpO2)lower than 92% under supplemental oxygen; b) need of supplemental oxygen >5 L/min; and RR ≥ 30 bpm .Re-intubation postoperative or intubation, period of ventilator dependence (non-invasive or invasive ventilation) ≤ 48 hours

    Grade 4:Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with subsequent period of ventilator dependence exceeding 48 hours

    Grade 5:Death before hospital discharge



Secondary Outcome Measures :
  1. Oxygenation Index [ Time Frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4) ]
    Arterial partial pressure of oxygen divided by inspired oxygen concentration(PaO2/FiO2).

  2. Driving pressure [ Time Frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4) ]
    Driving pressure = Pplateau -PEEP

  3. Lung dynamic compliance [ Time Frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4),5 minutes after the end of surgery (T4) ]
    LCdyn = TV/(Pplat-PEEP)

  4. Modified lung ultrasound score [ Time Frame: Postoperative 1 hour ]
    The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children undergoing elective thoracoscopic pulmonary surgery.
  • Written informed consent.
  • Children under 5 years old (including 5 years old)
  • ASA classification 1-2
  • Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Low or Moderate Risk

Exclusion Criteria:

  • Symptoms of upper respiratory tract infection or pulmonary infection in the past 4 weeks, chest X-ray suggests pneumonia
  • Severe circulatory disease
  • Children with bullae
  • Intraoperative arterial blood pressure monitoring cannot be performed
  • Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Rated High Risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386901


Contacts
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Contact: liang Xu +8618681581752 leonnel@msn.com

Locations
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China, Guangdong
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518038
Contact: liang Xu    +8618681581752    leonnel@msn.com   
Principal Investigator: Jiaxiang Chen         
Sub-Investigator: liang Xu         
Sub-Investigator: Xiaoli Shi         
Sub-Investigator: Changsheng Liang         
Sub-Investigator: Xinggang Ma         
Sponsors and Collaborators
Jiaxiang Chen
Publications of Results:

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Responsible Party: Jiaxiang Chen, Postgraduate Student, Shantou University Medical College
ClinicalTrials.gov Identifier: NCT05386901    
Other Study ID Numbers: 13229547507
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediately following publication and with no end date
Access Criteria:

Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal.

Proposals should be directed to Dr Jiaxiang Chen; e mail address:cjxanes@163.com

To gain access, data requestors will need to sign a data Access agreement.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiaxiang Chen, Shantou University Medical College:
Lung dynamic compliance
Positive end-expiratory pressure(PEEP)
One-lung ventilation(OLV)
Lung protection strategy
Postoperative pulmonary complications(PPCs)