Clinical trial · Interventional
The PROtective Ventilation Using Open Lung Approach Or Not Trial
Effects of Open Lung Approach on Intraoperative Respiratory Function and Postoperative Recovery of Patients With Laparoscopic Colorectal Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pulmonary Complications | — | UNRESOLVED | — |
| Respiratory Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| open lung approach | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- open lung approach ventilation strategy
- description
- Procedure: 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.
- interventionNames
- Procedure: open lung approach
- type
- NO_INTERVENTION
- label
- conventional ventilation strategy
- description
- Procedure: 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.
Primary outcomes (1)
- measure
- Occurrence rate of major pulmonary and extrapulmonary complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 40 years. 2. Undergo elective laparoscopic resection of colorectal cancer. 3. With an expected duration of pneumoperitoneum ≥1.5h. 4. With a preoperative risk index for pulmonary complications ≥ 2. 5. With no contraindication of epidural anesthesia. 6. Pulse oxygen saturation in air ≥ 92%. 7. And informed consent obtained. Exclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status ≥ IV. 2. Body mass index ≥30kg/m2. 3. Duration of mechanical ventilation ≥ 1h within 2 weeks preceding surgery. 4. A history of acute respiratory failure within 1 month preceding surgery. 5. With a sepsis or septic shock or instable hemodynamics. 6. With a progressive neuromuscular illness such as myasthenia gravis. 7. With a epilepsy or schizophrenia or Parkinson's disease. 8. With a severe chronic obstructive pulmonary disease (COPD) or pulmonary bulla. 9. Severe organ dysfunction (acute coronary syndrome, uremia, hepatic encephalopathy, classification of function capacity of the NYHA ≥III, malignant arrhythmia and so on). 10. Coma, severe cognitive deficit, language or hearing impairment who cannot communicate. 11. Not proper controlled hypertension. 12. Involved in other clinical studies or refused to join in the research.
References
Publications (34)
- BACKGROUNDSmetana GW. Preoperative pulmonary evaluation. N Engl J Med. 1999 Mar 25;340(12):937-44. doi: 10.1056/NEJM199903253401207. No abstract available. PMID 10089188
- BACKGROUNDFernandez-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. PMID 27829093
- BACKGROUNDBrooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71. doi: 10.1378/chest.111.3.564. PMID 9118688
- BACKGROUNDSlutsky 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. PMID 24283226
- BACKGROUNDGajic 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. PMID 15343007
- BACKGROUNDLee 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. PMID 11030175
- BACKGROUNDAcute 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.