Effects of Different Ventilation Patterns on Lung Injury

NCT ID: NCT03960853

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-12-31

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.

Detailed Description

One hundred patients undergoing elective laparoscopic colorectal cancer resection (age > 65 years old, body mass index(BMI）18-30 kg/m2, American society of anesthesiologists(ASA )grading Ⅰ - Ⅲ ) will be randomly assigned to volume control ventilation(VCV)group and pressure controlled ventilation-volume guarantee(PCV-VG)group.General anesthesia combined with epidural anesthesia will be used to both groups.

Ventilation settings in both groups are VT 8 mL/kg,inspiratory/expiratory (I/E) ratio 1:2,inspired oxygen concentration (FIO2) 0.5 with air,2.0 L/min of inspiratory fresh gas flow,positive end-expiratory pressure (PEEP) 0 millimeter of mercury （mmHg）,respiratory rate (RR) was adjusted to maintain an end tidal CO2 pressure (ETCO2) of 35 -45 mmHg.

In operation dates will be collected at the following time points: preanesthesia, 1 hour after pneumoperitoneum,2 hours after pneumoperitoneum ,30 minutes after admission to post-anaesthesia care unit (PACU) .The dates collected or calculated are the following:1)peak airway pressure,plate airway pressure, mean inspiratory pressure, dynamic compliance, RR,Exhaled VT andETCO2，2) Arterial blood gas analysis: arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2),power of hydrogen（PH）, and oxygen saturation (SaO2)，3) Oxygenation index (OI) calculation; PaO2/FIO2, 4) Ratio of physiologic dead-space over tidal volume(Vd/VT) (expressed in %) was calculated with Bohr's formula ; Vd/VT = (PaCO2 - ETCO2)/PaCO2,5) Hemodynamics: heart rate, mean arterial pressure (MAP),and central venous pressure （CVP），6) lung injury markers ：Interleukin 6(IL6）,Interleukin 8（IL8）,Clara cell protein 16（CC16）,Solution advanced glycation end products receptor（SRAGE）,tumor necrosis factor α(TNFα) .

Investigators will collect the following dates according to following-up after surgery: the incidence of postoperation pulmonary complications(PPC) based on PPC scale within seven days , incidence of pneumonia within seven days after surgery,incidence of atelectasis within seven days after surgery,length of hospital days after surgery, the incidence of postoperative unplanned admission to ICU, the incidence of operation complications within 7 days after surgery, the incidence of postoperative systematic complications within 7 days after surgery.

Conditions

Lung Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

pressure-controlled ventilation-volume guaranteed

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

Group Type: EXPERIMENTAL

pressure-controlled ventilation-volume guaranteed

Intervention Type: PROCEDURE

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

volume controlled ventilation

patients will be allocated to volume controlled ventilation in operation

Group Type: PLACEBO_COMPARATOR

volume controlled ventilation

Intervention Type: PROCEDURE

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

Interventions

pressure-controlled ventilation-volume guaranteed

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

Intervention Type: PROCEDURE

volume controlled ventilation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. scheduled for Laparoscopic colorectal cancer resection

2. age >65 years

3. body mass index(BMI) 18-30kg / m2

4. ASA gradingⅠ-Ⅲ

Exclusion Criteria

1. history of lung surgery

2. 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

3. 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

4. Patients at risk of preoperative reflux aspiration

5. Preoperative positive pressure ventilation (as obstructive sleep apnea hypopnea syndrome patients) or long-term home oxygen therapy were performed

6. 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

7. Neuromuscular diseases affect respiratory function, such as Parkinson's disease, myasthenia gravis and cerebral infarction affect normal breathing

8. Mental illness, speech impairment, hearing impairment

9. Contraindications for spinal anesthesia puncture

10. Refuse to participate in this study or participate in other studies -

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Dongxue Li

Principal Investigator, The department of anesthesiology ,Sixth Affiliated Hospital, Sun Yat-sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanqing Jin, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Dongxue Li

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Six Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongxue Li

Role: CONTACT

liguoqing2010@126.com

008615802037417

Facility Contacts

Dongxue Li

Role: primary

liguoqing2010@126.com

08615802037417

Sanqing Jin, MD

Role: backup

13719366863

References

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

Reference Type: BACKGROUND

PMID: 5235461 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24283226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22491953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26643095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28673814 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25232415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21377341 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 29176377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20167583 (View on PubMed)

Other Identifiers

2019ZSLYEC-184

Identifier Type: -

Identifier Source: org_study_id