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Effects of Different Ventilation Patterns on Lung Injury

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ClinicalTrials.gov Identifier: NCT03960853
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dongxue Li, Sixth Affiliated Hospital, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Lung Injury Procedure: pressure-controlled ventilation-volume guaranteed Procedure: volume controlled ventilation Not Applicable

Detailed Description:

Four hundreds patients undergoing elective laparoscopic colorectal cancer resection (age > 65 years old, BMI 18-30 kg/m2, 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)6mmHg,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 ,Steward score reached 6 points in postoperation care unit .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), 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 CVP,6) lung injury markers (IL6,IL8,CC16,SRAGE,TNFa) .

Investigators will collect the following dates according to following-up after surgery: the incidence of postoperation pulmonary complications 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: pressure-controlled ventilation-volume guaranteed
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
Procedure: pressure-controlled ventilation-volume guaranteed
patients will be allocated to pressure-controlled ventilation-volume guaranteed in operation

Placebo Comparator: volume controlled ventilation
patients will be allocated to volume controlled ventilation in operation
Procedure: volume controlled ventilation
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation




Primary Outcome Measures :
  1. assessing change of Oxygenation index [ Time Frame: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after admission to PACU ]
    Oxygenation index(OI)=PaO2/FiO2


Secondary Outcome Measures :
  1. Occurrence rate of pulmonary complications [ Time Frame: Day 0 to 7 after surgery ]
    Pulmonary complications (PPCs) 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.

  2. incidence of pneumonia [ Time Frame: Day 0 to 7 after surgery ]
    record the occurrence rate of pneumonia after surgery

  3. incidence of pulmonary atelectasis [ Time Frame: Day 0 to 7 after surgery ]
    record the occurrence rate of pulmonary atelectasis after surgery

  4. peak airway pressurec [ Time Frame: through mechanical ventilation,average of 3 hours ]
    Peak airway Pressure(Ppeak, cm H2O)

  5. Plateau airway pressure [ Time Frame: through mechanical ventilation,average of 3 hours ]
    Plateau airway pressure(Pplat, cm H2O)

  6. Static lung compliance [ Time Frame: through mechanical ventilation,average of 3 hours ]
    Static lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat−PEEP)

  7. Dynamic lung compliance [ Time Frame: through mechanical ventilation,average of 3 hours ]
    Dynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak−PEEP)

  8. Arterial partial pressure of oxygen [ Time Frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after admission to PACU ]
    Arterial partial pressure of oxygen (PaO2, mmHg)

  9. assessing change of Alveolar-arterial oxygen tension difference [ Time Frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after admission to PACU ]
    Alveolar-arterial oxygen tension difference (A-aDO2, mmHg)

  10. assessing change of Respiratory index [ Time Frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after admission to PACU ]
    Fraction of inspired oxygen (FiO2); Respiratory index (RI) = P(A-a)DO2/ FiO2

  11. assessing change of Alveolar dead space fraction [ Time Frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after admission to PACU ]
    Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in endexpiratory gas (PetCO2); Alveolar dead space fraction (Vd/Vt)=(PaCO2-PetCO2)/ PaCO2;

  12. assessing change of Lactic acid [ Time Frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after admission to PACU ]
    Lactic acid ( LAC, mmol/L)

  13. assessing change of Advanced glycation end products receptor [ Time Frame: 10 minutes before anesthesia,30 minutes after admission to PACU ]
    Advanced glycation end products receptor (RAGE, pg/ml)

  14. assessing change of Tumor Necrosis Factor alpha [ Time Frame: 10 minutes before anesthesia,30 minutes after admission to PACU ]
    Tumor Necrosis Factor alpha (TNF-α, pg/ml)

  15. assessing change of Interleukin 6 [ Time Frame: 10 minutes before anesthesia,30 minutes after admission to PACU ]
    Interleukin 6 (IL-6, pg/ml)

  16. assessing change of Interleukin 8 [ Time Frame: 10 minutes before anesthesia,30 minutes after admission to PACU ]
    Interleukin 8 (IL-8, pg/ml)

  17. assessing change of Clara cell protein 16, [ Time Frame: 10 minutes before anesthesia,30 minutes after admission to PACU ]
    Clara cell protein 16,

  18. The occurrence rate of hypoxemia in PACU [ Time Frame: 30 minutes after admission to PACU ]
    The occurrence rate of hypoxemia (PaO2<60 mmhg) in PACU

  19. Occurrence rate of operation complications [ Time Frame: within 7 days after operation ]
    abdominal abscess, anastomotic fistula, bleeding and the incidence of reoperation within 7 days

  20. Occurrence rate of Systemic complications [ Time Frame: within 7 days after surgery ]
    Systemic complications including sepsis and septic shock

  21. Antibiotic dosages [ Time Frame: within 7 days after surgery ]
    record the Antibiotic dosages within 7 days after surgery

  22. incidence of Unplanned admission to ICU [ Time Frame: within 30 days after surgery ]
    Unplanned admission to ICU within 30 days after surgery

  23. Length of ICU stay within 30 days after surgery [ Time Frame: within 30 days after surgery ]
    Length of ICU stay within 30 days after surgery

  24. Length of hospital stay within 30 days after surgery [ Time Frame: within 30 days after surgery ]
    Length of hospital stay within 30 days after surgery

  25. Death from any cause [ Time Frame: within 30 days after surgery ]
    Death from any cause 30 days after surgery

  26. incidence of oxygenation index≤300 in operation [ Time Frame: 10minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after admission to PACU ]
    record the incidence of oxygenation index(PaO2/FiO2)≤300 in operation



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. scheduled for Laparoscopic colorectal cancer resection
  2. age >65 years
  3. BMI18-30kg / m2
  4. ASA gradingⅠ-Ⅲ

Exclusion Criteria:

  1. history of lung surgery
  2. severe restrictive or obstructive pulmonary disease (preoperative lung function test: FVC < 50% predictive value of FVC, FEV1 < 50% predictive value of FEV1)
  3. Acute respiratory failure, pulmonary infection, ALI/ARDS, and acute stage of asthmaAcute respiratory failure, pulmonary infection, ALI/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 syndrom 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960853


Contacts
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Contact: Dongxue Li 008615802037417 liguoqing2010@126.com

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Principal Investigator: Sanqing Jin, MD Sixth Affiliated Hospital, Sun Yat-sen University
Principal Investigator: Dongxue Li Sixth Affiliated Hospital, Sun Yat-sen University

Publications:

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Responsible Party: Dongxue Li, Principal Investigator, The department of anesthesiology ,Sixth Affiliated Hospital, Sun Yat-sen University, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03960853     History of Changes
Other Study ID Numbers: 2019ZSLYEC-052
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dongxue Li, Sixth Affiliated Hospital, Sun Yat-sen University:
aged
mechanical ventilation,

Additional relevant MeSH terms:
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Wounds and Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries