The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation
- Conditions
- Mechanical PowerPostoperative Pulmonary ComplicationsAlveolar Recruitment ManeuversProtective Ventilation
- Interventions
- Other: periodic alveolar recruitment maneuversOther: positive end-expiratory pressure
- Registration Number
- NCT05962125
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
- Had an intermediate risk of developing postoperative pulmonary complications.
- Pulse oxygen saturation in room air ≥ 94%.
- Aged 60 to 80 years.
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Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.
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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.
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Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description a combination of PEEP and PARM positive end-expiratory pressure Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O. periodic alveolar recruitment maneuvers (PARM) alone periodic alveolar recruitment maneuvers Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. a combination of PEEP and PARM periodic alveolar recruitment maneuvers Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O. positive end-expiratory pressure (PEEP) alone positive end-expiratory pressure PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O.
- Primary Outcome Measures
Name Time Method Intraoperative mechanical power Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½\[Pplat - PEEP\] + \[Ppeak - Pplat\])
- Secondary Outcome Measures
Name Time Method Mechanical power during capnoperitoneum 30 minutes after starting carbon dioxide pneumoperitoneum mechanical power, J/min
Shunt fraction Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery Shunt fraction, %
Postoperative pulmonary complications score Day 0 to 3 after surgery Postoperative pulmonary complications score: Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).
Rate of need for vasoconstrictors During intraoperative mechanical ventilation, an average of 3 hours MAP \< 60 mmHg and using any vasoconstrictors.
Soluble advanced glycation end products receptor (sRAGE) 20 minutes after entering PACU The concentration of plasma sRAGE, pg/ml
Postoperative hospitalization days Day 0 to 30 after surgery The duration between the operation date and the actual discharge date.
Death from any cause Day 0 to 30 after surgery Intraoperative or postoperative death from any cause
Rate of intraoperative hypotension During intraoperative mechanical ventilation, an average of 3 hours Intraoperative hypotension, mean arterial pressure (MAP) \< 60 mmHg lasting more than 3 minutes.
Rate of intraoperative bradycardia During intraoperative mechanical ventilation, an average of 3 hours Intraoperative bradycardia, heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes.
Rate of respiratory failure at post-anesthesia care unit (PACU) Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU Respiratory failure: PaO2 \< 60 mmHg or pulse oxygen saturation (SpO2) \< 90% on room air, or a P/F ratio \< 300 mmHg and requiring oxygen therapy.
Surfactant Protein D (SP-D) 20 minutes after entering PACU The concentration of plasma SP-D, ug/ml
Rate of sustained hypoxaemia Day 0 to 3 after surgery Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.
Accumulative mechanical power (AMP) During intraoperative mechanical ventilation, an average of 3 hours Accumulative mechanical power (AMP) = AMP before capnoperitoneum + AMP during capnoperitoneum + AMP after capnoperitoneum. Accumulative mechanical power before capnoperitoneum = mechanical power before capnoperitoneum (10 min after mechanical ventilation) × the length of mechanical ventilation before capnoperitoneum. Accumulative mechanical power during capnoperitoneum = mechanical power during capnoperitoneum (30 min after mechanical ventilation) × the length of mechanical ventilation during capnoperitoneum. Accumulative mechanical power after capnoperitoneum (after the end of capnoperitoneum) = mechanical power after capnoperitoneum (10 min after the end of capnoperitoneum) × the length of mechanical ventilation after capnoperitoneum
An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio) Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery P/F ratio, mmHg
Dead space rate Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.
Clara cell protein 16 (CC16) 20 minutes after entering PACU The concentration of plasma CC16, ng/ml
Interleukin 6 (IL-6) 20 minutes after entering PACU The concentration of plasma IL-6, pg/ml
Rate of postoperative respiratory failure Time Frame: Day 0 to 3 after surgery Respiratory failure: PaO2 \< 60 mmHg or SpO2 \< 90% on room air, or a P/F ratio \< 300 mmHg and requiring oxygen therapy.
Rate of pneumothorax During surgery or within 7 days after surgery Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.
Rate of pleural effusion within 7 days after surgery Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).
Unexpected admission to ICU within 30 days after surgery It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.
Tumor Necrosis Factor alpha (TNF-α) 20 minutes after entering PACU TNF-α, pg/ml.
Rate of intraoperative hypoxemia During intraoperative mechanical ventilation, an average of 3 hours Intraoperative hypoxemia, SpO2 ≤ 92% lasting more than 3 minutes.
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China