Extrapulmonary Lung Protection Strategy for Patients With Mechanical Ventilation

NCT03947476 | Unknown

• 1 other identifier: EXPECT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

As an important life sustaining support , mechanical ventilation has greatly promoted the development of modern intensive care units. However, mechanical ventilation can lead to ventilator-induced lung injury, including barotrauma, volutrauma, atelectrauma and biotrauma. All patients undergoing mechanical ventilation are at risk of barotrauma. A multicenter prospective cohort study of 5183 patients with mechanical ventilation showed that the incidence of pulmonary barotrauma was 3%. The incidence of pulmonary barotrauma varied according to the causes of mechanical ventilation: chronic obstructive pulmonary disease (3%), asthma (6%), chronic interstitial lung disease (10%), acute respiratory distress syndrome (7%) and pneumonia (4%). At present, it is considered that one of the main causes of barotrauma is the increasing of transpulmonary pressure. Transpulmonary pressure is the difference between alveolar pressure and intrapleural pressure. The commonly adopted lung protective ventilation methods include: limiting plateau pressure less than or equal to 30 cmH2O, using small tidal volume ventilation (6-8 mL/kg ideal body weight) . All the above methods are to reduce trans-pulmonary pressure by reducing alveolar pressure. In addition to reducing alveolar pressure, increasing pleural pressure is another important way to reduce transpulmonary pressure and the incidence of barotrauma. At present, the main method is the use of neuromuscular blockade. However, there are many shortcomings in of neuromuscular blockade: 1. Time limit, generally not more than 48 hours; 2. Long-term use of neuromuscular blockade causes adverse reactions such as myopathy; 3. Neuromuscular blockade are only suitable for invasive mechanical ventilation patients, but not for non-invasive mechanical ventilation or high flow oxygen inhalation patients. Therefore, it is urgent to find other methods to reduce trans-pulmonary pressure and lung injury. The investigators drew inspiration from the early mechanism of "iron lung" ventilator and the clinical practice of reducing trans-pulmonary pressure and lung injury in obese patients. In the early stage, the investigators carried out the clinical practice of extrapulmonary lung protection strategy, that is, to give thoracic band restraint to patients undergoing non-invasive mechanical ventilation so as to reduce chest wall compliance, which can be significantly reduced under the same inspiratory pressure and occurrence of barotrauma. However, the respiratory mechanics mechanism of this method still needs to be further studied to determine whether it can reduce the incidence of barotrauma by reducing transpulmonary pressure. It is accessible and inexpensive. The aim of this study was to determine the changes of transpulmonary pressure in patients with invasive mechanical ventilation before and after thoracic band fixation by esophageal manometry without spontaneous breathing.

Conditions

Mechanical Ventilation; Ventilator-induced Lung Injury; Transpulmonary Pressure

Outcome Measures

Primary Outcomes (2)

• Inspiratory of transpulmonary pressure

  Measurement of transpulmonary pressure by placement of esophageal manometer tube during inspiratory,the metric is cmH2O

  up to 24 hours

• Expiratory of transpulmonary pressure

  Measurement of transpulmonary pressure by placement of esophageal manometer tube during expiratory,the metric is cmH2O

  up to 24 hours

Interventions

thoracic band DEVICE

Thoracic band fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit who need invasive mechanical ventilation at least 12 hours

You may qualify if:

• BMI \> 18, BMI \< 40
• Age \> 18 years old
• Patients who need invasive mechanical ventilation for lower abdominal surgery, brain surgery, cerebral hemorrhage and cerebral infarction
• Mechanical ventilation at least 12 hours

You may not qualify if:

• BMI \< 18 or BMI \> 40
• Age \< 18 years old
• abstain from nasogastric tube
• Pneumothorax
• Pregnant women
• Patients with severe hypoxemia

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Ju Minjie

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Minjie Ju, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yimei Liu, master

CONTACT

+8613916646834; liuyimei1988@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 5, 2019

Record last verified: 2019-05

Locations

CN (1)