Lung InjuryNCT03960853
Effects of Different Ventilation Patterns on Lung Injury
A study of Lung Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- scheduled for Laparoscopic colorectal cancer resection
- age >65 years
- body mass index(BMI) 18-30kg / m2
- ASA gradingⅠ-Ⅲ
Who cannot join
- 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
Show all 10Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Six Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Dongxue Li, 08615802037417, liguoqing2010@126.com
Sanqing Jin, MD, 13719366863
About this study
Official title: Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection
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.
Read the 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
- Being tested
- pressure-controlled ventilation-volume guaranteed, volume controlled ventilation
- Keywords
- aged, mechanical ventilation,
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure-controlled ventilation-volume guaranteedProcedure or surgery
patients will be allocated to pressure-controlled ventilation-volume guaranteed in operation
volume controlled ventilationProcedure or surgery
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
| Study group | Role | What they receive |
|---|---|---|
| pressure-controlled ventilation-volume guaranteed | Experimental | patients will be allocated to pressure-controlled ventilation volume guaranteed in operation Receives: Procedure: pressure-controlled ventilation-volume guaranteed |
| volume controlled ventilation | Placebo comparator | patients will be allocated to volume controlled ventilation in operation Receives: Procedure: volume controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence rate of Oxygenation index≤300mmHg
Oxygenation index(OI)=PaO2/FiO2
Measured: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation
Secondary outcomes (26)
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.
Measured: Day 0 to 7 after surgery
incidence of pneumonia
record the occurrence rate of pneumonia after surgery
Measured: Day 0 to 7 after surgery
incidence of pulmonary atelectasis
record the occurrence rate of pulmonary atelectasis after surgery
Measured: Day 0 to 7 after surgery
peak airway pressure
Peak airway Pressure（Ppeak, cm H2O)
Measured: through mechanical ventilation,average of 3 hours
Plateau airway pressure
Plateau airway pressure（Pplat, cm H2O）
Measured: through mechanical ventilation,average of 3 hours
Static lung compliance
Static lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat-PEEP)
Measured: through mechanical ventilation,average of 3 hours
Dynamic lung compliance
Dynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak-PEEP)
Measured: through mechanical ventilation,average of 3 hours
Arterial partial pressure of oxygen
Arterial partial pressure of oxygen (PaO2, mmHg）
Measured: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
assessing change of Alveolar-arterial oxygen tension difference
Alveolar-arterial oxygen tension difference (mmHg）
Measured: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
assessing change of Respiratory index
Fraction of inspired oxygen (FiO2); Respiratory index (RI) =Ratio of alveolar-arterial oxygen tension difference to FiO2
Measured: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
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;
Measured: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubation
assessing change of lactic acid
lactate ( LAC), mmol/L
Measured: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
assessing change of Advanced glycation end products receptor
Advanced glycation end products receptor (RAGE, pg/ml)
Measured: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Tumor Necrosis Factor alpha
Tumor Necrosis Factor alpha (TNF-α, pg/ml)
Measured: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Interleukin 6
Interleukin 6 (IL-6, pg/ml)
Measured: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Interleukin 8
Interleukin 8 (IL-8, pg/ml)
Measured: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Clara cell protein 16,
Clara cell protein 16,
Measured: 10 minutes before anesthesia,30 minutes after extubation
The occurrence rate of hypoxemia in PACU
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) in PACU
Measured: 30 minutes after extubation
Occurrence rate of operation complications
abdominal abscess, anastomotic fistula, bleeding and the incidence of reoperation within 7 days
Measured: within 7 days after operation
Occurrence rate of Systemic complications
Systemic complications including sepsis and septic shock
Measured: within 7 days after surgery
Antibiotic dosages
record the Antibiotic dosages within 7 days after surgery
Measured: within 7 days after surgery
incidence of Unplanned admission to ICU
Unplanned admission to ICU within 30 days after surgery
Measured: within 30 days after surgery
Length of ICU stay within 30 days after surgery
Length of ICU stay within 30 days after surgery
Measured: within 30 days after surgery
Length of hospital stay within 30 days after surgery
Length of hospital stay within 30 days after surgery
Measured: within 30 days after surgery
Death from any cause
Death from any cause 30 days after surgery
Measured: within 30 days after surgery
The occurrence rate of hypoxemia after surgery
The occurrence rate of hypoxemia (SPO2<90% or PaO2<60 mmHg) after surgery
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongxue Li, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Sanqing Jin, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen UniversityDongxue Li, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960853
- Sponsor's protocol ID
- 2019ZSLYEC-184
- Status last verified
- Jun 2019
- First submitted
- 19 May 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Respirator lung syndrome. Minn Med. 1967 Nov;50(11):1693-705. No abstract available.
PubMed 5235461Slutsky 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.
PubMed 24283226Needham 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.
PubMed 22491953Ball 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.
PubMed 26643095Mahmoud 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.
PubMed 28673814Dion 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.
PubMed 25232415Choi 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.
PubMed 21377341Tran D, Rajwani K, Berlin DA. Pulmonary effects of aging. Curr Opin Anaesthesiol. 2018 Feb;31(1):19-23. doi: 10.1097/ACO.0000000000000546.
PubMed 29176377Kalmar 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.
PubMed 20167583
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection
- ClinicalTrials.gov ID
- NCT03960853
- Acronym / sponsor ID
- 2019ZSLYEC-184
- Conditions
- Lung Injury
- Keywords
- aged, mechanical ventilation,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pressure-controlled ventilation-volume guaranteed | Experimental | Procedure: pressure-controlled ventilation-volume guaranteedpatients will be allocated to pressure-controlled ventilation volume guaranteed in operation |
| volume controlled ventilation | Placebo comparator | Procedure: volume controlled ventilationpatients will be allocated to volume controlled ventilation in operation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- scheduled for Laparoscopic colorectal cancer resection
- age >65 years
- body mass index(BMI) 18-30kg / m2
- ASA gradingⅠ-Ⅲ
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure-controlled ventilation-volume guaranteedpatients will be allocated to pressure-controlled ventilation-volume guaranteed in operation | Procedure or surgery | pressure-controlled ventilation-volume guaranteed |
| volume controlled ventilationpatients will be allocated to pressure-controlled ventilation volume guaranteed in operation | Procedure or surgery | volume controlled ventilation |
Primary outcome
occurrence rate of Oxygenation index≤300mmHg
Time frame: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation
Oxygenation index(OI)=PaO2/FiO2
26 secondary outcomes
Occurrence rate of pulmonary complications
Time frame: Day 0 to 7 after surgery
incidence of pneumonia
Time frame: Day 0 to 7 after surgery
incidence of pulmonary atelectasis
Time frame: Day 0 to 7 after surgery
peak airway pressure
Time frame: through mechanical ventilation,average of 3 hours
Plateau airway pressure
Time frame: through mechanical ventilation,average of 3 hours
Static lung compliance
Time frame: through mechanical ventilation,average of 3 hours
Dynamic lung compliance
Time frame: through mechanical ventilation,average of 3 hours
Arterial partial pressure of oxygen
Time frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
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 extubation
assessing change of Respiratory index
Time frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
assessing change of Alveolar dead space fraction
Time frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubation
assessing change of lactic acid
Time frame: 10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation
assessing change of Advanced glycation end products receptor
Time frame: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Tumor Necrosis Factor alpha
Time frame: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Interleukin 6
Time frame: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Interleukin 8
Time frame: 10 minutes before anesthesia,30 minutes after extubation
assessing change of Clara cell protein 16,
Time frame: 10 minutes before anesthesia,30 minutes after extubation
The occurrence rate of hypoxemia in PACU
Time frame: 30 minutes after extubation
Occurrence rate of operation complications
Time frame: within 7 days after operation
Occurrence rate of Systemic complications
Time frame: within 7 days after surgery
Antibiotic dosages
Time frame: within 7 days after surgery
incidence of Unplanned admission to ICU
Time frame: within 30 days after surgery
Length of ICU stay within 30 days after surgery
Time frame: within 30 days after surgery
Length of hospital stay within 30 days after surgery
Time frame: within 30 days after surgery
Death from any cause
Time frame: within 30 days after surgery
The occurrence rate of hypoxemia after surgery
Time frame: within 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 5235461Respirator lung syndrome. Minn Med. 1967 Nov;50(11):1693-705. No abstract available.
- Background: PubMed 24283226Slutsky 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.
- Background: PubMed 22491953Needham 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.
- Background: PubMed 26643095Ball 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.
- Background: PubMed 28673814Mahmoud 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.
- Background: PubMed 25232415Dion 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.
- Background: PubMed 21377341Choi 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.
- Background: PubMed 29176377Tran D, Rajwani K, Berlin DA. Pulmonary effects of aging. Curr Opin Anaesthesiol. 2018 Feb;31(1):19-23. doi: 10.1097/ACO.0000000000000546.
- Background: PubMed 20167583Kalmar 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanqing Jin, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Dongxue Li principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lung Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongxue Li (008615802037417, liguoqing2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence rate of Oxygenation index≤300mmHg (time frame: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960853, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.