Effects of Different Ventilation Patterns on Lung Injury

NCT03960853 | Unknown

• 1 other identifier: 2019ZSLYEC-184
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In 1967, the term "respirator lung" was coined to describe the diffuse alveolar infiltrates and hyaline membranes that were found on postmortem examination of patients who had undergone mechanical ventilation.This mechanical ventilation can aggravate damaged lungs and damage normal lungs. In recent years, Various ventilation strategies have been used to minimize lung injury, including low tide volume, higher PEEPs, recruitment maneuvers and high-frequency oscillatory ventilation. which have been proved to reduce the occurrence of lung injury. In 2012,Needham et al. proposed a kind of lung protective mechanical ventilation, and their study showed that limited volume and pressure ventilation could significantly improve the 2-year survival rate of patients with acute lung injury.Volume controlled ventilation is the most commonly used method in clinical surgery at present.Volume controlled ventilation(VCV) is a time-cycled, volume targeted ventilation mode, ensures adequate gas exchange. Nevertheless, during VCV, airway pressure is not controlled.Pressure controlled ventilation（PCV） can ensure airway pressure,however minute ventilation is not guaranteed.Pressure controlled ventilation-volume guarantee(PCV-VG) is an innovative mode of ventilation utilizes a decelerating flow and constant pressure. Ventilator parameters are automatically changed with each patient breath to offer the target VT without increasing airway pressures. So PCV-VG has the advantages of both VCV and PCV to preserve the target minute ventilation whilst producing a low incidence of barotrauma pressure-targeted ventilation. Current studies on PCV-VG mainly focus on thoracic surgery, bariatric surgery and urological surgery, and the research indicators mainly focus on changes in airway pressure and intraoperative oxygenation index.The age of patients undergoing laparoscopic colorectal cancer resection is generally higher, the cardiopulmonary reserve function is decreased, and the influence of intraoperative pneumoperitoneum pressure and low head position increases the incidence of intraoperative and postoperative pulmonary complications.Whether PCV-VG can reduce the incidence of intraoperative lung injury and postoperative pulmonary complications in elderly patients undergoing laparoscopic colorectal cancer resection, and thereby improve postoperative recovery of these patients is still unclear.

Conditions

Lung Injury

Keywords

aged; mechanical ventilation,

Outcome Measures

Primary Outcomes (1)

• occurrence rate of Oxygenation index≤300mmHg

  Oxygenation index(OI)=PaO2/FiO2

  10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation

Secondary Outcomes (26)

• Occurrence rate of pulmonary complications

  Day 0 to 7 after surgery

• incidence of pneumonia

  Day 0 to 7 after surgery

• incidence of pulmonary atelectasis

  Day 0 to 7 after surgery

• peak airway pressure

  through mechanical ventilation,average of 3 hours

• Plateau airway pressure

  through mechanical ventilation,average of 3 hours

Study Arms (2)

pressure-controlled ventilation-volume guaranteed

EXPERIMENTAL

patients will be allocated to pressure-controlled ventilation volume guaranteed in operation

Procedure: pressure-controlled ventilation-volume guaranteed

volume controlled ventilation

PLACEBO COMPARATOR

patients will be allocated to volume controlled ventilation in operation

Procedure: volume controlled ventilation

Interventions

pressure-controlled ventilation-volume guaranteed PROCEDURE

patients will be allocated to pressure-controlled ventilation-volume guaranteed in operation

pressure-controlled ventilation-volume guaranteed

volume controlled ventilation PROCEDURE

patients will be allocated to pressure-controlled ventilation volume guaranteed in operation

volume controlled ventilation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• scheduled for Laparoscopic colorectal cancer resection
• age \>65 years
• body mass index(BMI) 18-30kg / m2
• ASA gradingⅠ-Ⅲ

You may not qualify if:

• history of lung surgery
• severe restrictive or obstructive pulmonary disease (preoperative lung function test: forced vital capacity(FVC)\< 50% predictive value of FVC,forced expiratory volume at one second(FEV1)\< 50% predictive value of FEV1
• Acute respiratory failure, pulmonary infection, ALI/ARDS, and acute stage of asthmaAcute respiratory failure, pulmonary infection, acute lung injury(ALI),acute respiratory distress syndrome(ARDS), and acute stage of asthma (bronchodilators were needed for treatment) were found within 1 month before surgery
• Patients at risk of preoperative reflux aspiration
• Preoperative positive pressure ventilation (as obstructive sleep apnea hypopnea syndrome patients) or long-term home oxygen therapy were performed
• Serious heart, liver and kidney diseases: heart function class more than 3, severe arrhythmia (sinus bradycardia (ventricular rate \< 60 times/min), atrial fibrillation, atrial flutter, atrioventricular block, frequent premature ventricular and polyphyly ventricular early, early to R on T, ventricular fibrillation and ventricular flutter), acute coronary syndrome, liver failure, kidney failure
• Neuromuscular diseases affect respiratory function, such as Parkinson's disease, myasthenia gravis and cerebral infarction affect normal breathing
• Mental illness, speech impairment, hearing impairment
• Contraindications for spinal anesthesia puncture
• Refuse to participate in this study or participate in other studies -

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Six Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (9)

• Respirator lung syndrome. Minn Med. 1967 Nov;50(11):1693-705. No abstract available.

  PMID: 5235461 BACKGROUND

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

  PMID: 24283226 BACKGROUND

• Needham DM, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Sevransky JE, Dennison Himmelfarb CR, Desai SV, Shanholtz C, Brower RG, Pronovost PJ. Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study. BMJ. 2012 Apr 5;344:e2124. doi: 10.1136/bmj.e2124.

  PMID: 22491953 BACKGROUND

• Ball L, Dameri M, Pelosi P. Modes of mechanical ventilation for the operating room. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):285-99. doi: 10.1016/j.bpa.2015.08.003. Epub 2015 Sep 2.

  PMID: 26643095 BACKGROUND

• Mahmoud K, Ammar A, Kasemy Z. Comparison Between Pressure-Regulated Volume-Controlled and Volume-Controlled Ventilation on Oxygenation Parameters, Airway Pressures, and Immune Modulation During Thoracic Surgery. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1760-1766. doi: 10.1053/j.jvca.2017.03.026. Epub 2017 Mar 22.

  PMID: 28673814 BACKGROUND

• Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 2014 Aug 15;7(8):2242-7. eCollection 2014.

  PMID: 25232415 BACKGROUND

• Choi EM, Na S, Choi SH, An J, Rha KH, Oh YJ. Comparison of volume-controlled and pressure-controlled ventilation in steep Trendelenburg position for robot-assisted laparoscopic radical prostatectomy. J Clin Anesth. 2011 May;23(3):183-8. doi: 10.1016/j.jclinane.2010.08.006. Epub 2011 Mar 4.

  PMID: 21377341 BACKGROUND

• Tran D, Rajwani K, Berlin DA. Pulmonary effects of aging. Curr Opin Anaesthesiol. 2018 Feb;31(1):19-23. doi: 10.1097/ACO.0000000000000546.

  PMID: 29176377 BACKGROUND

• Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.

  PMID: 20167583 BACKGROUND

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Sanqing Jin, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Dongxue Li

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongxue Li

CONTACT

008615802037417; liguoqing2010@126.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, The department of anesthesiology ,Sixth Affiliated Hospital, Sun Yat-sen University

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 23, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 7, 2020

Record last verified: 2019-06

Locations

CN (1)