Alveolar Recruitment Maneuvers, Mechanical Power, Postoperative Pulmonary Complications, Protective Ventilation
Conditions
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.
Interventions
OTHERperiodic alveolar recruitment maneuvers
A stepwise increment of tidal volume was used for each ARM.
OTHERpositive end-expiratory pressure
a PEEP of 6 to 8 cm H2O
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Shunt fraction | Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery | Shunt fraction, % |
| 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. |
| 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. |
| Soluble advanced glycation end products receptor (sRAGE) | 20 minutes after entering PACU | The concentration of plasma sRAGE, pg/ml |
| Clara cell protein 16 (CC16) | 20 minutes after entering PACU | The concentration of plasma CC16, ng/ml |
| Surfactant Protein D (SP-D) | 20 minutes after entering PACU | The concentration of plasma SP-D, ug/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 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%. |
| Mechanical power during capnoperitoneum | 30 minutes after starting carbon dioxide pneumoperitoneum | mechanical power, J/min |
| 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 need for vasoconstrictors | During intraoperative mechanical ventilation, an average of 3 hours | MAP \< 60 mmHg and using any vasoconstrictors. |
| Rate of intraoperative hypoxemia | During intraoperative mechanical ventilation, an average of 3 hours | Intraoperative hypoxemia, SpO2 ≤ 92% 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 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. |
| 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). |
Countries
China
Outcome results
None listed