Clinical trial NCT03960853: Effects of Different Ventilation Patterns on Lung Injury
Official title: Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Injury
Keywords: aged
mechanical ventilation,
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 -

Primary outcomes:
measure: occurrence rate of Oxygenation index≤300mmHg
timeFrame: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation
Secondary outcomes:
measure: Occurrence rate of pulmonary complications
timeFrame: Day 0 to 7 after surgery
measure: incidence of pneumonia
timeFrame: Day 0 to 7 after surgery
measure: incidence of pulmonary atelectasis
timeFrame: Day 0 to 7 after surgery
measure: peak airway pressure
timeFrame: through mechanical ventilation,average of 3 hours
measure: Plateau airway pressure
timeFrame: through mechanical ventilation,average of 3 hours
measure: Static lung compliance
timeFrame: through mechanical ventilation,average of 3 hours
measure: Dynamic lung compliance
timeFrame: through mechanical ventilation,average of 3 hours
measure: Arterial partial pressure of oxygen
timeFrame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
measure: assessing change of Alveolar-arterial oxygen tension difference
timeFrame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
measure: assessing change of Respiratory index
timeFrame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
measure: assessing change of Alveolar dead space fraction
timeFrame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubation
measure: assessing change of lactic acid
timeFrame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
measure: assessing change of Advanced glycation end products receptor
timeFrame: 10 minutes before anesthesia,30 minutes after extubation
measure: assessing change of Tumor Necrosis Factor alpha
timeFrame: 10 minutes before anesthesia,30 minutes after extubation
measure: assessing change of Interleukin 6
timeFrame: 10 minutes before anesthesia,30 minutes after extubation
measure: assessing change of Interleukin 8
timeFrame: 10 minutes before anesthesia,30 minutes after extubation
measure: assessing change of Clara cell protein 16,
timeFrame: 10 minutes before anesthesia,30 minutes after extubation
measure: The occurrence rate of hypoxemia in PACU
timeFrame: 30 minutes after extubation
measure: Occurrence rate of operation complications
timeFrame: within 7 days after operation
measure: Occurrence rate of Systemic complications
timeFrame: within 7 days after surgery
measure: Antibiotic dosages
timeFrame: within 7 days after surgery
measure: incidence of Unplanned admission to ICU
timeFrame: within 30 days after surgery
measure: Length of ICU stay within 30 days after surgery
timeFrame: within 30 days after surgery
measure: Length of hospital stay within 30 days after surgery
timeFrame: within 30 days after surgery
measure: Death from any cause
timeFrame: within 30 days after surgery
measure: The occurrence rate of hypoxemia after surgery
timeFrame: within 7 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Six Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Sanqing Jin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Dongxue Li
role: PRINCIPAL_INVESTIGATOR
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