NCT05386901

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

May 17, 2022

Last Update Submit

October 27, 2023

Conditions

AnesthesiaSurgery

Keywords

Lung dynamic compliancePositive end-expiratory pressure(PEEP)One-lung ventilation(OLV)Lung protection strategyPostoperative pulmonary complications(PPCs)

Outcome Measures

Primary Outcomes (1)

  • Postoperative pulmonary complication(PPCs) rate at 7 days

    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

    7 days after surgery

Secondary Outcomes (4)

  • Oxygenation Index

    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

    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)

  • Lung dynamic compliance

    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)

  • Modified lung ultrasound score

    Postoperative 1 hour

Study Arms (2)

Conventional positive end-expiratory pressure(PEEP)

EXPERIMENTAL

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)

Lung dynamic compliance guided positive end-expiratory pressure(PEEP)

EXPERIMENTAL

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)

Interventions

Conventional positive end-expiratory pressure(PEEP)PROCEDURE

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.

Conventional positive end-expiratory pressure(PEEP)
Lung dynamic compliance guided positive end-expiratory pressure(PEEP)PROCEDURE

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.

Lung dynamic compliance guided positive end-expiratory pressure(PEEP)

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518038, China

Location

Related Publications (13)

  • Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.

    PMID: 28322416RESULT

  • Templeton TW, Miller SA, Lee LK, Kheterpal S, Mathis MR, Goenaga-Diaz EJ, Templeton LB, Saha AK; Multicenter Perioperative Outcomes Group Investigators. Hypoxemia in Young Children Undergoing One-lung Ventilation: A Retrospective Cohort Study. Anesthesiology. 2021 Nov 1;135(5):842-853. doi: 10.1097/ALN.0000000000003971.

    PMID: 34543405RESULT

  • Chandler D, Mosieri C, Kallurkar A, Pham AD, Okada LK, Kaye RJ, Cornett EM, Fox CJ, Urman RD, Kaye AD. Perioperative strategies for the reduction of postoperative pulmonary complications. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):153-166. doi: 10.1016/j.bpa.2020.04.011. Epub 2020 Apr 23.

    PMID: 32711826RESULT

  • iPROVE Network investigators; Belda J, Ferrando C, Garutti I. The Effects of an Open-Lung Approach During One-Lung Ventilation on Postoperative Pulmonary Complications and Driving Pressure: A Descriptive, Multicenter National Study. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2665-2672. doi: 10.1053/j.jvca.2018.03.028. Epub 2018 Mar 27.

    PMID: 29709437RESULT

  • Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.

    PMID: 32682552RESULT

  • Xu D, Wei W, Chen L, Li S, Lian M. Effects of different positive end-expiratory pressure titrating strategies on oxygenation and respiratory mechanics during one- lung ventilation: a randomized controlled trial. Ann Palliat Med. 2021 Feb;10(2):1133-1144. doi: 10.21037/apm-19-441. Epub 2020 Sep 15.

    PMID: 32954753RESULT

  • Zhou ZF, Fang JB, Wang HF, He Y, Yu YJ, Xu Q, Ge YF, Zhang MZ, Hu SF. Effects of intraoperative PEEP on postoperative pulmonary complications in high-risk patients undergoing laparoscopic abdominal surgery: study protocol for a randomised controlled trial. BMJ Open. 2019 Oct 30;9(10):e028464. doi: 10.1136/bmjopen-2018-028464.

    PMID: 31672709RESULT

  • 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.

    PMID: 30916035RESULT

  • Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.

    PMID: 30776290RESULT

  • Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

    PMID: 28973363RESULT

  • Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.

    PMID: 24901240RESULT

  • Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.

    PMID: 30260897RESULT

  • Chen J, Lin R, Shi X, Liang C, Hu W, Ma X, Xu L. Effects of individualised lung-protective ventilation with lung dynamic compliance-guided positive end-expiratory pressure titration on postoperative pulmonary complications of paediatric video-assisted thoracoscopic surgery: protocol for a randomised controlled trial. BMJ Paediatr Open. 2024 Jul 16;8(1):e002359. doi: 10.1136/bmjpo-2023-002359.

    PMID: 39019541DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postgraduate Student

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 23, 2022

Study Start

June 10, 2022

Primary Completion

June 1, 2024

Study Completion

October 1, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

CN(1)