Driving Pressure and Postoperative Pulmonary Complications in Thoracic Surgery

NCT04260451 | Completed

• 1 other identifier: SMC2019-07-182-009
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.

Conditions

One-Lung Ventilation; Postoperative Complications; Driving Pressure; Postoperative Pulmonary Complication; Thoracic Surgery; Positive End Expiratory Pressure

Keywords

Postoperative pulmonary complication; Driving pressure; Thoracic surgery; One lung ventilation; Positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

• the incidence of postoperative pulmonary complications

  Postoperative pulmonary complications are defined as one or more of the following: * Hypoxia: SpO2 \< 90% * Requiring oxygen therapy: Facial mask, nasal prong, continuous positive airway pressure, non-invasive positive pressure breathing or high flow nasal oxygen supply between POD 2 and 7. * Initial ventilator supports longer than 24 h * Re-intubation * Requiring mechanical ventilation * Tracheostomy * Pneumonia * Empyema * Atelectasis requiring bronchoscopy * Acute respiratory distress syndrome * Acute lung injury * Persistent emphysema or pneumothorax or air leak requiring chest tube for 5 days or more * Prolonged pleural effusion requiring chest tube for 5 days or more * Bronchopleural fistula * Contralateral pneumothorax * Pulmonary embolism embolism

  within the first 7 days after surgery

Secondary Outcomes (16)

• oxygenation

  15 minutes after one-lung ventilation

• the incidence of rescue ventilation

  during surgery

• Cstat

  15 minutes after one-lung ventilation

• CRP

  within the first 1 days after surgery

• the incidence of postoperative transfusion

  within the first 3 days after surgery

Study Arms (2)

Driving pressure group

EXPERIMENTAL

Positive end expiratory pressure is adjusted to tidal volume of 5 mL/kg of ideal body weight, inspiratory:expiratory=1:2, and minimize driving pressure (plateau pressure minus end expiratory pressure) during one-lung ventilation. Other procedures are same with the control arm.

Other: ventilation

Protective Ventilation

NO INTERVENTION

The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and positive end expiratory pressure of 5cmH2O during one-lung ventilation

Interventions

ventilation OTHER

Driving Pressure Limited Ventilation Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation. 1\. Lung recruitment: stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg, inspiratory:expiratory 1:1, respiratory rate 10. and driving pressure up to 20 cmH2O. Then decremental PEEP titration is performed using a volume-controlled ventilation until the lowest driving pressure (plateau pressure minus PEEP) is found. This individualized PEEP is adjusted during one-lung ventilation.

Driving pressure group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than or equal to 19 years with American Society of Anesthesiologists physical status Ⅰ-Ⅲ Patient who undergoes one-lung ventilation (more than 60 minutes) for elective thoracic surgery

You may not qualify if:

• The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
• Symptoms of heart failure (hypertension, urination, pulmonary edema, left ventricular outflow rate \<45%) or preoperative vasopressors
• Patient who is received oxygen therapy and ventilation care
• large emphysema and pneumothorax
• pregnancy and lactation
• patients participating in similar studies
• Joint with other operation
• Patient who rejects being enrolled in the study
• Patients with elevated intracranial pressure
• Patients with peripheral neuropathy or blood circulation disorders
• Patients with hematology disease
• Congenital heart disease with shunt

Sponsors & Collaborators

• Samsung Medical Center: lead
• Severance Hospital: collaborator
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• The Catholic University of Korea: collaborator

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Park M, Yoon S, Nam JS, Ahn HJ, Kim H, Kim HJ, Choi H, Kim HK, Blank RS, Yun SC, Lee DK, Yang M, Kim JA, Song I, Kim BR, Bahk JH, Kim J, Lee S, Choi IC, Oh YJ, Hwang W, Lim BG, Heo BY. Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial. Br J Anaesth. 2023 Jan;130(1):e106-e118. doi: 10.1016/j.bja.2022.06.037. Epub 2022 Aug 20.

  PMID: 35995638 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 7, 2020
• Study Start: March 2, 2020
• Primary Completion: April 15, 2021
• Study Completion: May 31, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

KR (1)