Clinical trial NCT05962125: The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation
Official title: Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Power
Alveolar Recruitment Maneuvers
Protective Ventilation
Postoperative Pulmonary Complications
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers \[ARM\] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.


Eligibility criteria: Inclusion Criteria:

1. Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
2. Had an intermediate risk of developing postoperative pulmonary complications.
3. Pulse oxygen saturation in room air ≥ 94%.
4. Aged 60 to 80 years.

Exclusion Criteria:

* 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.

  2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.

  6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.

Primary outcomes:
measure: Intraoperative mechanical power
timeFrame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Secondary outcomes:
measure: Mechanical power during capnoperitoneum
timeFrame: 30 minutes after starting carbon dioxide pneumoperitoneum
measure: Accumulative mechanical power (AMP)
timeFrame: During intraoperative mechanical ventilation, an average of 3 hours
measure: An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)
timeFrame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
measure: Shunt fraction
timeFrame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
measure: Dead space rate
timeFrame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
measure: Rate of respiratory failure at post-anesthesia care unit (PACU)
timeFrame: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU
measure: Soluble advanced glycation end products receptor (sRAGE)
timeFrame: 20 minutes after entering PACU
measure: Clara cell protein 16 (CC16)
timeFrame: 20 minutes after entering PACU
measure: Surfactant Protein D (SP-D)
timeFrame: 20 minutes after entering PACU
measure: Interleukin 6 (IL-6)
timeFrame: 20 minutes after entering PACU
measure: Rate of postoperative respiratory failure
timeFrame: Time Frame: Day 0 to 3 after surgery
measure: Rate of sustained hypoxaemia
timeFrame: Day 0 to 3 after surgery
measure: Postoperative pulmonary complications score
timeFrame: Day 0 to 3 after surgery
measure: Postoperative hospitalization days
timeFrame: Day 0 to 30 after surgery
measure: Death from any cause
timeFrame: Day 0 to 30 after surgery
measure: Rate of intraoperative hypotension
timeFrame: During intraoperative mechanical ventilation, an average of 3 hours
measure: Rate of need for vasoconstrictors
timeFrame: During intraoperative mechanical ventilation, an average of 3 hours
measure: Rate of intraoperative hypoxemia
timeFrame: During intraoperative mechanical ventilation, an average of 3 hours
measure: Rate of intraoperative bradycardia
timeFrame: During intraoperative mechanical ventilation, an average of 3 hours
measure: Rate of pneumothorax
timeFrame: During surgery or within 7 days after surgery
measure: Rate of pleural effusion
timeFrame: within 7 days after surgery
measure: Unexpected admission to ICU
timeFrame: within 30 days after surgery
measure: Tumor Necrosis Factor alpha (TNF-α)
timeFrame: 20 minutes after entering PACU
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Hong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: