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Effects of Different Ventilation Patterns on Lung Injury

Primary Purpose

Lung Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pressure-controlled ventilation-volume guaranteed
volume controlled ventilation
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Injury focused on measuring aged, mechanical ventilation,

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Six Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pressure-controlled ventilation-volume guaranteed

volume controlled ventilation

Arm Description

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

patients will be allocated to volume controlled ventilation in operation

Outcomes

Primary Outcome Measures

occurrence rate of Oxygenation index≤300mmHg
Oxygenation index(OI)=PaO2/FiO2

Secondary Outcome Measures

Occurrence rate of pulmonary complications
Pulmonary 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 pneumonia
record the occurrence rate of pneumonia after surgery
incidence of pulmonary atelectasis
record the occurrence rate of pulmonary atelectasis after surgery
peak airway pressure
Peak airway Pressure(Ppeak, cm H2O)
Plateau airway pressure
Plateau airway pressure(Pplat, cm H2O)
Static lung compliance
Static lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat-PEEP)
Dynamic lung compliance
Dynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak-PEEP)
Arterial partial pressure of oxygen
Arterial partial pressure of oxygen (PaO2, mmHg)
assessing change of Alveolar-arterial oxygen tension difference
Alveolar-arterial oxygen tension difference (mmHg)
assessing change of Respiratory index
Fraction of inspired oxygen (FiO2); Respiratory index (RI) =Ratio of alveolar-arterial oxygen tension difference to FiO2
assessing change of Alveolar dead space fraction
Arterial 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 acid
lactate ( LAC), mmol/L
assessing change of Advanced glycation end products receptor
Advanced glycation end products receptor (RAGE, pg/ml)
assessing change of Tumor Necrosis Factor alpha
Tumor Necrosis Factor alpha (TNF-α, pg/ml)
assessing change of Interleukin 6
Interleukin 6 (IL-6, pg/ml)
assessing change of Interleukin 8
Interleukin 8 (IL-8, pg/ml)
assessing change of Clara cell protein 16,
Clara cell protein 16,
The occurrence rate of hypoxemia in PACU
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) in PACU
Occurrence rate of operation complications
abdominal abscess, anastomotic fistula, bleeding and the incidence of reoperation within 7 days
Occurrence rate of Systemic complications
Systemic complications including sepsis and septic shock
Antibiotic dosages
record the Antibiotic dosages within 7 days after surgery
incidence of Unplanned admission to ICU
Unplanned admission to ICU within 30 days after surgery
Length of ICU stay within 30 days after surgery
Length of ICU stay within 30 days after surgery
Length of hospital stay within 30 days after surgery
Length of hospital stay within 30 days after surgery
Death from any cause
Death from any cause 30 days after surgery
The occurrence rate of hypoxemia after surgery
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) after surgery

Full Information

First Posted
May 19, 2019
Last Updated
January 5, 2020
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03960853
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury
Keywords
aged, mechanical ventilation,

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pressure-controlled ventilation-volume guaranteed
Arm Type
Experimental
Arm Description
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
Arm Title
volume controlled ventilation
Arm Type
Placebo Comparator
Arm Description
patients will be allocated to volume controlled ventilation in operation
Intervention Type
Procedure
Intervention Name(s)
pressure-controlled ventilation-volume guaranteed
Intervention Description
patients will be allocated to pressure-controlled ventilation-volume guaranteed in operation
Intervention Type
Procedure
Intervention Name(s)
volume controlled ventilation
Intervention Description
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
Primary Outcome Measure Information:
Title
occurrence rate of Oxygenation index≤300mmHg
Description
Oxygenation index(OI)=PaO2/FiO2
Time Frame
10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation
Secondary Outcome Measure Information:
Title
Occurrence rate of pulmonary complications
Description
Pulmonary 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.
Time Frame
Day 0 to 7 after surgery
Title
incidence of pneumonia
Description
record the occurrence rate of pneumonia after surgery
Time Frame
Day 0 to 7 after surgery
Title
incidence of pulmonary atelectasis
Description
record the occurrence rate of pulmonary atelectasis after surgery
Time Frame
Day 0 to 7 after surgery
Title
peak airway pressure
Description
Peak airway Pressure(Ppeak, cm H2O)
Time Frame
through mechanical ventilation,average of 3 hours
Title
Plateau airway pressure
Description
Plateau airway pressure(Pplat, cm H2O)
Time Frame
through mechanical ventilation,average of 3 hours
Title
Static lung compliance
Description
Static lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat-PEEP)
Time Frame
through mechanical ventilation,average of 3 hours
Title
Dynamic lung compliance
Description
Dynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak-PEEP)
Time Frame
through mechanical ventilation,average of 3 hours
Title
Arterial partial pressure of oxygen
Description
Arterial partial pressure of oxygen (PaO2, mmHg)
Time Frame
10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
Title
assessing change of Alveolar-arterial oxygen tension difference
Description
Alveolar-arterial oxygen tension difference (mmHg)
Time Frame
10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
Title
assessing change of Respiratory index
Description
Fraction of inspired oxygen (FiO2); Respiratory index (RI) =Ratio of alveolar-arterial oxygen tension difference to FiO2
Time Frame
10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
Title
assessing change of Alveolar dead space fraction
Description
Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in endexpiratory gas (PetCO2); Alveolar dead space fraction (Vd/Vt)=(PaCO2-PetCO2)/ PaCO2;
Time Frame
10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubation
Title
assessing change of lactic acid
Description
lactate ( LAC), mmol/L
Time Frame
10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
Title
assessing change of Advanced glycation end products receptor
Description
Advanced glycation end products receptor (RAGE, pg/ml)
Time Frame
10 minutes before anesthesia,30 minutes after extubation
Title
assessing change of Tumor Necrosis Factor alpha
Description
Tumor Necrosis Factor alpha (TNF-α, pg/ml)
Time Frame
10 minutes before anesthesia,30 minutes after extubation
Title
assessing change of Interleukin 6
Description
Interleukin 6 (IL-6, pg/ml)
Time Frame
10 minutes before anesthesia,30 minutes after extubation
Title
assessing change of Interleukin 8
Description
Interleukin 8 (IL-8, pg/ml)
Time Frame
10 minutes before anesthesia,30 minutes after extubation
Title
assessing change of Clara cell protein 16,
Description
Clara cell protein 16,
Time Frame
10 minutes before anesthesia,30 minutes after extubation
Title
The occurrence rate of hypoxemia in PACU
Description
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) in PACU
Time Frame
30 minutes after extubation
Title
Occurrence rate of operation complications
Description
abdominal abscess, anastomotic fistula, bleeding and the incidence of reoperation within 7 days
Time Frame
within 7 days after operation
Title
Occurrence rate of Systemic complications
Description
Systemic complications including sepsis and septic shock
Time Frame
within 7 days after surgery
Title
Antibiotic dosages
Description
record the Antibiotic dosages within 7 days after surgery
Time Frame
within 7 days after surgery
Title
incidence of Unplanned admission to ICU
Description
Unplanned admission to ICU within 30 days after surgery
Time Frame
within 30 days after surgery
Title
Length of ICU stay within 30 days after surgery
Description
Length of ICU stay within 30 days after surgery
Time Frame
within 30 days after surgery
Title
Length of hospital stay within 30 days after surgery
Description
Length of hospital stay within 30 days after surgery
Time Frame
within 30 days after surgery
Title
Death from any cause
Description
Death from any cause 30 days after surgery
Time Frame
within 30 days after surgery
Title
The occurrence rate of hypoxemia after surgery
Description
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) after surgery
Time Frame
within 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: scheduled for Laparoscopic colorectal cancer resection age >65 years body mass index(BMI) 18-30kg / m2 ASA gradingⅠ-Ⅲ Exclusion Criteria: 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongxue Li
Phone
008615802037417
Email
liguoqing2010@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanqing Jin, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongxue Li
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Six Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongxue Li
Phone
08615802037417
Email
liguoqing2010@126.com
First Name & Middle Initial & Last Name & Degree
Sanqing Jin, MD
Phone
13719366863

12. IPD Sharing Statement

Citations:
PubMed Identifier
5235461
Citation
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Results Reference
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PubMed Identifier
22491953
Citation
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.
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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Citation
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.
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Effects of Different Ventilation Patterns on Lung Injury

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