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Postoperative Pulmonary ComplicationsPROVOLONNCT03160144

The PROtective Ventilation Using Open Lung Approach Or Not Trial

A study testing open lung approach in people with Postoperative Pulmonary Complications and Respiratory Insufficiency, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Postoperative Pulmonary Complications (PPC) are very common. It severely affects postoperative recovery, particularly in the abdominal surgery. Patients with laparoscopic resection of colorectal cancer generally have a higher age and decreased lung function reserve. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
open lung approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
12 Jan 2017to 12 Oct 2018
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 40 years.
  • Undergo elective laparoscopic resection of colorectal cancer.
  • With an expected duration of pneumoperitoneum ≥1.5h.
  • With a preoperative risk index for pulmonary complications ≥ 2.
  • With no contraindication of epidural anesthesia.
  • Pulse oxygen saturation in air ≥ 92%.
  • And informed consent obtained.

Who cannot join

  • American Society of Anesthesiologists (ASA) physical status ≥ IV.
  • Body mass index ≥30kg/m2.
  • Duration of mechanical ventilation ≥ 1h within 2 weeks preceding surgery.
  • A history of acute respiratory failure within 1 month preceding surgery.
  • With a sepsis or septic shock or instable hemodynamics.
  • With a progressive neuromuscular illness such as myasthenia gravis.
Show all 12Show fewer
  • With a epilepsy or schizophrenia or Parkinson's disease.
  • With a severe chronic obstructive pulmonary disease (COPD) or pulmonary bulla.
  • Severe organ dysfunction (acute coronary syndrome, uremia, hepatic encephalopathy, classification of function capacity of the NYHA ≥III, malignant arrhythmia and so on).
  • Coma, severe cognitive deficit, language or hearing impairment who cannot communicate.
  • Not proper controlled hypertension.
  • Involved in other clinical studies or refused to join in the research.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The sixth affiliated hospital of Sun Yat-Sen university

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: Effects of Open Lung Approach on Intraoperative Respiratory Function and Postoperative Recovery of Patients With Laparoscopic Colorectal Resection

Postoperative Pulmonary Complications (PPC) are very common. It severely affects postoperative recovery, particularly in the abdominal surgery. Patients with laparoscopic resection of colorectal cancer generally have a higher age and decreased lung function reserve. At the same time, they prone to developing atelectasis due to the effects of pneumoperitoneum pressure. Therefore, they are a high-risk group of respiratory insufficiency and PPC.

Mechanical ventilation with a low tidal volume is a routine in clinic nowadays. However, this conventional strategy will also result in atelectasis formation. Therefore, it may deteriorate the vulnerable lung function of patients undergoing laparoscopic resection of colorectal cancer. Patients with Acute Lung Injury or Acute Respiratory Distress Syndrome (ALI/ARDS) could benefit from the "open lung approach", including the use of positive end-expiratory pressure (PEEP) and recruitment maneuvers (RMs). Whether a lung protective mechanical ventilation strategy with medium levels of PEEP and repeated RMs, the "open lung approach", protects against respiratory insufficiency and PPC during laparoscopic resection of colorectal cancer is uncertain. The present study aims at comparing the effects of "open lung approach" mechanical ventilation strategy and conventional mechanical ventilation strategy in PPC, extra-pulmonary complications, length of hospital stay, biomarkers of lung injury and changes of respiratory function in patients undergoing general anesthesia for laparoscopic resection of colorectal cancer.

Read the detailed description
  1. Sample size calculation, randomization and patients safety. The required sample size is calculated from previous studies on the incidence of postoperative pulmonary complications. A two group chi-square test with a 0.05 two-sided significance level will have 80% power to detect the difference (in primary outcome) between conventional mechanical ventilation strategy (25%) and open lung approach mechanical ventilation strategy (12.5%) when the sample size in each group is 126. In consideration of a 10% loss rate, 280 cases to be included in this trial. Research will be carried out in two stages. Completely-randomized design was used in the first stage, and randomized block design in the second stage. The interim analysis will be performed when 100 patients (first stage) have successfully been included and followed-up. The Data Monitoring and Safety Group (DMSG) will provide recommendations about stopping or continuing the trial to the principal investigator. The DMSG will recommend stopping the trial, if significant group-difference in adverse events is found at the interim analysis (p<0.025), or if postoperative pulmonary complications occur more frequently in the intervention group (p<0.025). If the intervention has a strong trend for improving postoperative pulmonary complications (p<0.018) at the first stage, termination of the study is considered.
  2. Protocol drop-out. Anesthesiologists are allowed to change the ventilation protocol if there is any concern about patient's safety. The level of PEEP can be modified according to the anesthesiologist in charge if the systolic arterial pressure (SBP)< 80 mmHg and SBP drop ≥30% baseline values for more than 3 minutes despite intravenous fluid infusion and/or start of vasopressors, if dosages of vasopressors are at the highest level tolerated, if new arrhythmias develop which are unresponsive to treatment suggested by the Advanced Cardiac Life Support Guidelines. If there is pneumothorax or hypoxemia (SpO2 < 90% for more than 3 minutes）, if there is need of massive transfusion (>8 units packed red blood cell) to maintain hemoglobin >7 mg/dl, if the duration of pneumoperitoneum is less then 1h or mechanical ventilation time is less then 2h, if there is a surgical complication (such as severe hypercapnia, unexpected conversion to open surgery, unplanned reoperation in 24h after surgery, unplanned ICU admission for surgical reasons) or if patient die during operation, then the patient will be dropped out of the study. All drop-out cases will be included in the safety analysis.
  3. Trial settings for intraoperative ventilation. Patients in the conventional mechanical ventilation strategy group will have a tidal volume of 6 to 8 ml per kilogram Predicted Body Weight (PBW), zero PEEP and no recruitment maneuver. Patients in the open lung approach mechanical ventilation strategy group will have a tidal volume of 6 to 8 ml per kilogram PBW, a PEEP level of 6 to 8 cm of water and recruitment maneuvers. Recruitment maneuvers consist of a stepwise increase of tidal volume （as detailed below） and will be applied immediately after tracheal intubation and every 30 min thereafter until the end of surgery. In each group, anesthesiologists will be advised to use an inspired oxygen fraction (FIO2) between 0.4 to 0.5 and to maintain oxygen saturation ≥ 92%. The inspiratory to expiratory time ratio will be set at 1:2, with a respiratory rate adjusted to maintain normocapnia (end-tidal carbon dioxide concentration of 30-50 mmHg). PBW is calculated according to a predefined formula with: 50 + 0.91 x (centimeters of height - 152.4) for males and 45.5 + 0.91 x (centimeters of height - 152.4) for females. In each group, patients will be ventilated using the volume-controlled ventilation strategy using an anesthesia ventilator: 1. Avance® (Datex-Ohmeda, General Electric, Helsinki, Finland) 2. Tiro® (Dräger, Lübeck, Germany)
  4. Recruitment maneuvers. Stepwise increase of tidal volume will be used as a method of recruitment maneuvers in this trial. Recruitment maneuvers should not be performed when patients are hemodynamic unstable, as judged by the attending anesthesiologist. Recruitment maneuvers will be performed as follows: 4-1. Peak inspiratory pressure limit is set at 45 cmH2O. 4-2. Tidal volume is set at 8 ml/kg PBW and respiratory rate at 6 breaths/min, while PEEP is set at 12 cmH2O. 4-3. Inspiratory to expiratory ratio (I:E) is set at 1:2. 4-4. Tidal volumes are increased in steps of 4 ml/kg PBW until a plateau pressure of 30-35 cmH2O (if tidal volume reach the biggest volume of the ventilator and plateau pressure cannot reach 30-35 cmH2O, then PEEP is set at 16 cmH2O for a plateau pressure of 30-35 cmH2O). 4-5. Three breaths are administered with a plateau pressure of 30-35 cmH2O. 4-6. Peak inspiratory pressure limit, respiratory rate, I: E, and tidal volume are set back to settings preceding each recruitment maneuver, while maintaining PEEP at 8 cmH2O.
  5. Definitions for postoperative complications. All definitions for postoperative complications refer to the IMPROVE trial and the PROVHILO trial.
  6. Composition and responsibilities of the DMSG. Members of the DMSG are the management team of anesthesia department in the research hospital. The DMSG will be responsible for safeguarding the interests of trial participants, assessing the safety and efficacy of the intervention during the trial, and for monitoring the overall conduct of the trial. To enhance the integrity of the trial, the DMSG may also formulate recommendations relating to the selection or recruitment of participants, and the procedures of data management and quality control. The DMSG will be advisory to the principal investigator. The principal investigator will be responsible for reviewing the DMSG recommendations, decide whether to continue or terminate the trial, and determine whether changes in trial conduct are required. Any DMSG members who develop significant conflicts of interest during the course of the trial should resign from the DMSG.
  7. Data management. Data will be collected and recorded into case report forms (CRFs) by researchers under the supervision of DMSG members. Data manager will scan handwritten data first and then enter data into electronic database. Source data verification will be performed using a cross-check method by researchers when 7-days follow-up have successfully been completed. All adverse events, serious adverse events, unexpected or possibly related events will be recorded in the CRF and reported to the DMSG.
  8. Statistics. Statisticians will be in blind state for data analysis. Analysis will be by intention-to-treat comparing the primary outcome measure at 7 days in the two groups by chi-squared test (or Fisher's exact test as appropriate). Continuous variables will be compared using the One-way analysis of variance or the Mann-Whitney U test. Categorical variables will be compared using the chi-square test or the Fisher's exact test. The time-to-event curves will be calculated with the use of the Kaplan-Meier method. All analyses will be conducted using the SPSS 16.0 statistical software.
Being tested
open lung approach
Keywords
laparoscopic resection of colorectal cancer, open lung approach
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open lung approachProcedure or surgery

    Also called open lung strategy

Study groups in NCT03160144
Study groupRoleWhat they receive
open lung approach ventilation strategyExperimentalProcedure: open lung approach ventilation strategy (OLV). Patients receive volume-controlled mechanical ventilation with a tidal volume of 6 to 8 ml per kilogram of predicted body weight, a PEEP of 6 to 8 cm of water, and recruitment maneuvers repeated every 30 minutes after tracheal intubation.
Receives: Procedure: open lung approach
conventional ventilation strategyNo interventionProcedure: conventional ventilation strategy (NOLV). Patients receive volume-controlled mechanical ventilation with a tidal volume of 6 to 8 ml per kilogram of predicted body weight, no PEEP and no recruitment maneuver.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence rate of major pulmonary and extrapulmonary complications

    Major pulmonary complications were defined as suspected pneumonia，acute respiratory failure and sustained hypoxia; Major extrapulmonary complications were defined as sepsis, severe sepsis and septic shock or death.

    Measured: Day 0 to 7 after surgery

Secondary outcomes (38)

  1. Peak airway Pressure

    Peak airway Pressure（Ppeak, cm H2O);

    Measured: Intraoperative, period of mechanical ventilation

  2. Plateau airway pressure

    Plateau airway pressure（Pplat, cm H2O）;

    Measured: Intraoperative, period of mechanical ventilation

  3. Static lung compliance

    Static lung compliance (Csta, ml/cm H2O) = Vt/ (Pplat-PEEP);

    Measured: Intraoperative, period of mechanical ventilation

  4. Dynamic lung compliance

    Dynamic lung compliance (Cdyn , ml/cm H2O)= Vt/ (Ppeak-PEEP);

    Measured: Intraoperative, period of mechanical ventilation

  5. Arterial partial pressure of oxygen

    Arterial partial pressure of oxygen (PaO2, mmHg）; post-anaesthesia care unit (PACU);

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  6. Alveolar-arterial oxygen tension difference

    Alveolar-arterial oxygen tension difference (A-aDO2, mmHg）;

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  7. Arterial- alveolar oxygen tension ratio

    Alveolar oxygen pressure (PAO2); Arterial- alveolar oxygen tension ratio ( a / A ratio) =PaO2 / PAO2;

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  8. Respiratory index

    Fraction of inspired oxygen (FiO2); Respiratory index (RI) = P(A-a)DO2/ FiO2;

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  9. Oxygenation index

    Oxygenation index (OI)=PaO2/FiO2;

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  10. 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: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  11. Lactic acid

    Lactic acid ( LAC, mmol/L);

    Measured: pre-anesthesia, 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  12. Oxygen extraction ratio

    Oxygen content of central venous blood (CvO2); Oxygen content of arterial blood (CaO2); oxygen extraction ratio (O2ER)＝(CaO2-CvO2) /CaO2;

    Measured: The first stage of the study: 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  13. Central venous blood oxygen saturation

    Central venous blood oxygen saturation (ScvO2).

    Measured: The first stage of the study: 0.5 hour after pneumoperitoneum, 1.5 hours after pneumoperitoneum, 20 minutes after entering PACU

  14. Advanced glycation end products receptor

    Advanced glycation end products receptor (RAGE, pg/ml).

    Measured: Intraoperative (pre-anesthesia, post-operation) and postoperative (postoperative day 3)

  15. S100 beta protein

    S100 beta protein （S100β, μg/L）.

    Measured: Intraoperative (pre-anesthesia, post-operation) and postoperative (postoperative day 3)

  16. Tumor Necrosis Factor alpha

    Tumor Necrosis Factor alpha (TNF-α, pg/ml);

    Measured: Intraoperative (pre-anesthesia, post-operation) and postoperative (postoperative day 3)

  17. Interleukin 6

    Interleukin 6 (IL-6, pg/ml).

    Measured: Intraoperative (pre-anesthesia, post-operation) and postoperative (postoperative day 3)

  18. The occurrence rate of hypoxemia in PACU

    The occurrence rate of hypoxemia (PaO2<60 mmhg) in PACU

    Measured: 20 minutes after entering PACU

  19. Length of PACU stay

    Length of PACU stay (min);

    Measured: Though study completion, an average of half an hour.

  20. The recovery time from anesthesia

    The recovery time from anesthesia (min).

    Measured: Though study completion, an average of one hour.

  21. Postoperative pulmonary complications

    The incidence of postoperative pulmonary complications based on a PPC scale.

    Measured: Day 0 to 7 after surgery

  22. Postoperative acute respiratory failure

    Occurrence rate of acute respiratory failure (SpO2< 90% or PaO2<60mmhg);

    Measured: Day 0 to 7 after surgery

  23. Postoperative suspected pneumonia

    Occurrence rate of postoperative pneumonia;

    Measured: Day 0 to 7 after surgery

  24. Pulse oximetry less than 92%

    Occurrence rate of saturation of pulse oximetry less than 92%;

    Measured: Day 0 to 7 after surgery

  25. Sustained hypoxia

    Occurrence rate of sustained hypoxia

    Measured: Day 0 to 7 after surgery

  26. Saturation of pulse oximetry

    Saturation of pulse oximetry (SpO2);

    Measured: Day 0 to 7 after surgery

  27. Occurrence rate of intervention-related adverse events

    Intervention-related adverse events including: rescue therapy for desaturation, potentially harmful hypotension, pneumothorax, vasoactive drugs needed.

    Measured: Intraoperative, period of mechanical ventilation

  28. Postoperative delirium

    Postoperative delirium will be estimated by a scale called Confusion Assessment Method-ICU.

    Measured: Day 1 to 3 after surgery

  29. Occurrence rate of related complications

    Related complications including: the systemic inflammatory response syndrome (SIRS), acute myocardial infarction (AMI), Acute hepatic and renal insufficiency; surgical complications including intraabdominal abscess, anastomotic leakage.

    Measured: Day 0 to 7 after surgery

  30. Unplanned reoperation after 24h

    Unplanned reoperation after 24h (operation not caused by bleeding in 24h).

    Measured: Up to 30 days after surgery

  31. Postoperative hospital stay

    Postoperative hospital stay.

    Measured: Up to 30 days after surgery

  32. Lung recruitment maneuver systolic blood pressure changes

    Systolic blood pressure (SBP, mmHg);

    Measured: The first stage of the study: intraoperative, when lung recruitment maneuver is operated.

  33. Lung recruitment maneuver related diastolic blood pressure changes

    Diastolic blood pressure (DBP, mmHg);

    Measured: The first stage of the study: intraoperative, when lung recruitment maneuver is operated.

  34. Lung recruitment maneuver related mean arterial pressure changes

    Mean arterial pressure (MBP, mmHg); heart rate (HR, bpm).

    Measured: The first stage of the study: intraoperative, when lung recruitment maneuver is operated.

  35. Lung recruitment maneuver related heart rate changes

    Heart rate (HR, bpm).

    Measured: The first stage of the study: intraoperative, when lung recruitment maneuver is operated.

  36. Death from any cause.

    Death from any cause 30 days after surgery.

    Measured: Up to 30 days after surgery

  37. Unplanned admission to ICU

    Unplanned admission to ICU (not caused by bleeding in 24h).

    Measured: Up to 30 days after surgery

  38. Impaired oxygenation

    PaO2/FIO2 ≤ 300 mmHg

    Measured: before anesthesia induction, 0.5 h and 1.5 h after pneumoperitoneum induction, and 20 min after postanesthesia care unit (PACU) admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start12 Jan 2017
  3. Primary completion20 Sep 2018
  4. Study completion12 Oct 2018

Resources

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
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03160144
Sponsor's protocol ID
2017ZSLYEC-002
Acronym
PROVOLON
Status last verified
Dec 2019
First submitted
21 Apr 2017
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Smetana GW. Preoperative pulmonary evaluation. N Engl J Med. 1999 Mar 25;340(12):937-44. doi: 10.1056/NEJM199903253401207. No abstract available.

    PubMed 10089188

  • Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.

    PubMed 27829093

  • Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71. doi: 10.1378/chest.111.3.564.

    PubMed 9118688

  • Slutsky 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 24283226

  • Gajic O, Dara SI, Mendez JL, Adesanya AO, Festic E, Caples SM, Rana R, St Sauver JL, Lymp JF, Afessa B, Hubmayr RD. Ventilator-associated lung injury in patients without acute lung injury at the onset of mechanical ventilation. Crit Care Med. 2004 Sep;32(9):1817-24. doi: 10.1097/01.ccm.0000133019.52531.30.

    PubMed 15343007

  • Lee WL, Detsky AS, Stewart TE. Lung-protective mechanical ventilation strategies in ARDS. Intensive Care Med. 2000 Aug;26(8):1151-5. doi: 10.1007/s001340051332. No abstract available.

    PubMed 11030175

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PubMed 10793162

  • Wanderer JP, Blum JM, Ehrenfeld JM. Intraoperative low-tidal-volume ventilation. N Engl J Med. 2013 Nov 7;369(19):1861. doi: 10.1056/NEJMc1311316. No abstract available.

    PubMed 24195560

  • Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

    PubMed 23093163

  • Guay J, Ochroch EA. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in patients without acute lung injury. Cochrane Database Syst Rev. 2015 Dec 7;(12):CD011151. doi: 10.1002/14651858.CD011151.pub2.

    PubMed 26641378

  • Cox PN, Bryan AC. Small tidal volumes and the open-lung approach. Crit Care Med. 2001 Apr;29(4):915. doi: 10.1097/00003246-200104000-00056. No abstract available.

    PubMed 11373501

  • Rothen HU, Sporre B, Engberg G, Wegenius G, Hedenstierna G. Re-expansion of atelectasis during general anaesthesia: a computed tomography study. Br J Anaesth. 1993 Dec;71(6):788-95. doi: 10.1093/bja/71.6.788.

    PubMed 8280539

  • Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.

    PubMed 19809292

  • Jaber S, Coisel Y, Chanques G, Futier E, Constantin JM, Michelet P, Beaussier M, Lefrant JY, Allaouchiche B, Capdevila X, Marret E. A multicentre observational study of intra-operative ventilatory management during general anaesthesia: tidal volumes and relation to body weight. Anaesthesia. 2012 Sep;67(9):999-1008. doi: 10.1111/j.1365-2044.2012.07218.x. Epub 2012 Jun 18.

    PubMed 22708696

  • Hess DR, Kondili D, Burns E, Bittner EA, Schmidt UH. A 5-year observational study of lung-protective ventilation in the operating room: a single-center experience. J Crit Care. 2013 Aug;28(4):533.e9-15. doi: 10.1016/j.jcrc.2012.11.014. Epub 2013 Jan 29.

    PubMed 23369521

Questions about this trial

What is this clinical trial studying?

A study testing open lung approach in people with Postoperative Pulmonary Complications and Respiratory Insufficiency, 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 3 Dec 2019. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence rate of major pulmonary and extrapulmonary complications (time frame: Day 0 to 7 after surgery). 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 NCT03160144, which also lists 34 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 3 Dec 2019.

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