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Effects of Different Ventilation Patterns on Lung Injury

Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03960853
Enrollment
100
Registered
2019-05-23
Start date
2019-08-01
Completion date
2021-12-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Injury

Keywords

aged, mechanical ventilation,

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.

Interventions

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

PROCEDUREpressure-controlled ventilation-volume guaranteed

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

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
occurrence rate of Oxygenation index≤300mmHg10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubationOxygenation index(OI)=PaO2/FiO2

Secondary

MeasureTime frameDescription
Occurrence rate of pulmonary complicationsDay 0 to 7 after surgeryPulmonary complications were assessed using the Postoperation Pulmonary complication ( PPC) scale,The scale is divided into four grades, with 0 indicating no pulmonary complications and 1 to 4 indicating increasingly severe pulmonary complications.
incidence of pneumoniaDay 0 to 7 after surgeryrecord the occurrence rate of pneumonia after surgery
incidence of pulmonary atelectasisDay 0 to 7 after surgeryrecord the occurrence rate of pulmonary atelectasis after surgery
peak airway pressurethrough mechanical ventilation,average of 3 hoursPeak airway Pressure(Ppeak, cm H2O)
Plateau airway pressurethrough mechanical ventilation,average of 3 hoursPlateau airway pressure(Pplat, cm H2O)
Static lung compliancethrough mechanical ventilation,average of 3 hoursStatic lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat-PEEP)
Dynamic lung compliancethrough mechanical ventilation,average of 3 hoursDynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak-PEEP)
Arterial partial pressure of oxygen10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubationArterial partial pressure of oxygen (PaO2, mmHg)
assessing change of Alveolar-arterial oxygen tension difference10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubationAlveolar-arterial oxygen tension difference (mmHg)
assessing change of Respiratory index10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubationFraction of inspired oxygen (FiO2); Respiratory index (RI) =Ratio of alveolar-arterial oxygen tension difference to FiO2
assessing change of Alveolar dead space fraction10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubationArterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in endexpiratory gas (PetCO2); Alveolar dead space fraction (Vd/Vt)=(PaCO2-PetCO2)/ PaCO2;
assessing change of lactic acid10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubationlactate ( LAC), mmol/L
assessing change of Advanced glycation end products receptor10 minutes before anesthesia,30 minutes after extubationAdvanced glycation end products receptor (RAGE, pg/ml)
assessing change of Tumor Necrosis Factor alpha10 minutes before anesthesia,30 minutes after extubationTumor Necrosis Factor alpha (TNF-α, pg/ml)
assessing change of Interleukin 610 minutes before anesthesia,30 minutes after extubationInterleukin 6 (IL-6, pg/ml)
assessing change of Interleukin 810 minutes before anesthesia,30 minutes after extubationInterleukin 8 (IL-8, pg/ml)
assessing change of Clara cell protein 16,10 minutes before anesthesia,30 minutes after extubationClara cell protein 16,
The occurrence rate of hypoxemia in PACU30 minutes after extubationThe occurrence rate of hypoxemia (SPO2\<90% or PaO2\<60 mmHg) in PACU
Occurrence rate of operation complicationswithin 7 days after operationabdominal abscess, anastomotic fistula, bleeding and the incidence of reoperation within 7 days
Occurrence rate of Systemic complicationswithin 7 days after surgerySystemic complications including sepsis and septic shock
Antibiotic dosageswithin 7 days after surgeryrecord the Antibiotic dosages within 7 days after surgery
incidence of Unplanned admission to ICUwithin 30 days after surgeryUnplanned admission to ICU within 30 days after surgery
Length of ICU stay within 30 days after surgerywithin 30 days after surgeryLength of ICU stay within 30 days after surgery
Length of hospital stay within 30 days after surgerywithin 30 days after surgeryLength of hospital stay within 30 days after surgery
Death from any causewithin 30 days after surgeryDeath from any cause 30 days after surgery
The occurrence rate of hypoxemia after surgerywithin 7 days after surgeryThe occurrence rate of hypoxemia (SPO2\<90% or PaO2\<60 mmHg) after surgery

Countries

China

Contacts

Primary ContactDongxue Li
liguoqing2010@126.com008615802037417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026