The PROtective Ventilation Using Open Lung Approach Or Not Trial

NCT03160144 | Completed DMC

• 1 other identifier: 2017ZSLYEC-002
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 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

Postoperative Pulmonary Complications; Respiratory Insufficiency

Keywords

laparoscopic resection of colorectal cancer; open lung approach

Outcome Measures

Primary Outcomes (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.

  Day 0 to 7 after surgery

Secondary Outcomes (38)

• Peak airway Pressure

  Intraoperative, period of mechanical ventilation

• Plateau airway pressure

  Intraoperative, period of mechanical ventilation

• Static lung compliance

  Intraoperative, period of mechanical ventilation

• Dynamic lung compliance

  Intraoperative, period of mechanical ventilation

• Arterial partial pressure of oxygen

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

Study Arms (2)

open lung approach ventilation strategy

EXPERIMENTAL

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.

Procedure: open lung approach

conventional ventilation strategy

NO INTERVENTION

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.

Interventions

open lung approach PROCEDURE

Also known as: open lung strategy

open lung approach ventilation strategy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The sixth affiliated hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510655, China

Location

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  PMID: 36566186 DERIVED

• Li H, Zheng ZN, Zhang NR, Guo J, Wang K, Wang W, Li LG, Jin J, Tang J, Liao YJ, Jin SQ. Intra-operative open-lung ventilatory strategy reduces postoperative complications after laparoscopic colorectal cancer resection: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1042-1051. doi: 10.1097/EJA.0000000000001580.

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• Li H, Guo J, Wang K, Zhang NR, Zheng ZN, Jin SQ. [Effect of open-lung ventilation strategy on oxygenation-impairment during laparoscopic colorectal cancer resection]. Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Nov 25;23(11):1081-1087. doi: 10.3760/cma.j.issn.441530-20191209-00507. Chinese.

  PMID: 33212557 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Sanqing Jin, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Hong Li, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, The department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 19, 2017
• Study Start: January 12, 2017
• Primary Completion: September 20, 2018
• Study Completion: October 12, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

CN (1)