The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications

Официальное название

The Effect of Automatic Lung Re-expansion on Postoperative Pulmonary Function in Elderly Patients Undergoing Laparoscopic Surgery Under Total Intravenous Anesthesia: A Prospective, Single-center, Randomized Controlled Trial

Обзор

Study Background and Purpose As society ages, an increasing number of elderly patients undergo surgery. Following surgery, particularly abdominal procedures, patients are susceptible to lung-related issues such as atelectasis (lung collapse) and infection, collectively known as Postoperative Pulmonary Complications (PPCs). These complications are a major factor affecting the recovery of elderly patients. One method of general anesthesia is called Total Intravenous Anesthesia (TIVA). This study aims to investigate whether using an automated lung recruitment function, a smart feature available on modern anesthesia machines, can help protect lung function and reduce complications in elderly patients undergoing laparoscopic surgery under TIVA. The goal is to identify safer and more effective methods for anesthesia care. Study Design This is a clinical research study. Eligible elderly patients who provide consent will be randomly assigned to one of two groups: Study Group: The automated lung recruitment function on the anesthesia machine will be used to manage breathing during surgery. Control Group: Current standard methods for breathing management will be used during surgery. The primary goal is to observe and compare the blood oxygenation level 30 minutes after surgery (a key indicator of lung function) between the two groups. The investigators will also record the occurrence of any lung-related complications within the first 3 days after surgery. What Will Participants Do? If participants agree to participate, they will be asked to: Sign an informed consent form. Undergo some pre-operative assessments arranged by the research team. Receive the corresponding breathing management method during surgery, as determined by random assignment. Allow the research team to collect relevant medical data after surgery (e.g., blood gas analysis results, medical records). All data will be kept strictly confidential. Participation does not involve any additional invasive procedures. All medical care and monitoring will adhere to the standard safety protocols required for the surgery, and may even be more meticulous. Potential Benefits and Risks of the Study Potential Benefits: Direct Benefit: Participants will receive more precise monitoring and care for their respiratory function during and after surgery. Societal Value: Data from their participation will contribute to developing better anesthesia strategies for future elderly patients, potentially improving their recovery outcomes. Potential Risks and Protections: The study intervention is integrated into standard anesthesia. The main risks are associated with routine anesthesia and surgery itself (e.g., temporary blood pressure fluctuations, low oxygen levels). These risks are possible in any similar surgical procedure. The study will be conducted by experienced anesthesiologists with continuous, close monitoring. Comprehensive emergency plans are in place to ensure participant safety. Participants have the right to withdraw from the study at any time, for any reason, without affecting their eligibility for any future standard medical care. All personal information and study data will be kept strictly confidential. Data will be analyzed using coded identifiers only. Any published results will not contain information that could reveal the identity of participants.

Вмешательства

• Устройство Automated recruitment maneuver (Auto-RM)
  In addition to total intravenous anesthesia (TIVA) combined with volume-controlled ventilation (VCV), an automated recruitment maneuver was performed using the HuaSheng Lavender intravenous anesthesia machine at 10 minutes after intubation or laryngeal mask insertion and again at 10 minutes before the end of surgery. The maneuver employed the PEEP incremental method as follows: the ventilator was set to pressure-controlled ventilation (PCV) mode with a respiratory rate of 10 breaths/min, an insp

Первичные конечные точки

• oxygenation index (PaO₂/FiO₂ ratio) at 30 minutes after extubation [Срок оценки: 30 minutes after extubation]

Вторичные конечные точки (8)

• extubation time, duration of PACU stay after anesthesia [Срок оценки: until actual discharge from the PACU]
• Incidence of postoperative shivering [Срок оценки: Day 1]
• The incidence of pulmonary complications occurring within the first 7 days following surgery [Срок оценки: up to 7 days]
• Incidence of postoperative hypoxemia (SpO₂ < 94%) within 24 hours after surgery [Срок оценки: Day 1]
• QoR-15 (15-item Quality of Recovery) scores on postoperative days 1, 2, and 3 [Срок оценки: Days 1, 2, and 3]
• all-cause mortality within 30 days after surgery [Срок оценки: up to 30 days]
• Incidence of postoperative nausea and vomiting (PONV) at 24, 48, and 72 hours after surgery [Срок оценки: Days 1, 2 and 3]
• Postoperative NRS scores at 24, 48, and 72 hours [Срок оценки: Days 1, 2 and 3]

Критерии участия

Критерии включения

• aged≥65 years
• American Society of Anesthesiologists (ASA) grades I-III;
• Body mass index (BMI) between 18-30kg/m²
• No history of drug allergy or abnormal anesthesia;
• Patients undergoing laparoscopic gastrointestinal surgery, and operative time> 2 hours;
• Participants with a preoperative oxygen saturation not < 94%
• Participants for whom extubation is planned in the operating room.
• The assess respiratory risk in surgical patients in Catalonia (ARISCAT) score is 26-44 or > 44.

Критерии исключения

• ALI or ARDS patient within 3 months; severe pulmonary dysfunction; severe COPD (FEV1 <50% of predicted value) or pulmonary hypertension;
• New York Heart Association classification: Class IV;
• Chronic renal failure(GFR<30ml min-11.73m-2);
• Severe liver disease;
• Patients with confusion and cognitive dysfunction;
• Severe coagulation disorders;
• Patients with tracheal tubes transported to the ICU;
• Other reasons;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Ho — Цзинань

Публикации

• Ferrando C, Carraminana A, Pineiro P, Mirabella L, Spadaro S, Librero J, Ramasco F, Scaramuzzo G, Cervantes O, Garutti I, Parera A, Argilaga M, Herranz G, Unzueta C, Vives M, Regi K, Costa-Reverte M, Sonsoles Leal M, Nieves-Alonso J, Garcia E, Rodriguez-Perez A, Farina R, Cabrera S, Guerra E, Gallego-Ligorit L, Herrero-Izquierdo A, Valles-Torres J, Ramos S, Lopez-Herrera D, De La Matta M, Gokhan S PMID 38065200
• Chang YT, Shen CH. Total Intravenous Anesthesia and Postoperative Pulmonary Complications-Reply. JAMA Otolaryngol Head Neck Surg. 2023 Apr 1;149(4):376-377. doi: 10.1001/jamaoto.2022.4967. No abstract available. PMID 36757716
• Obara S, Oishi R, Nakano Y, Noji Y, Ebana H, Isosu T, Kurosawa S, Murakawa M. Update on the SedLine(R) algorithm for calculating the Patient State Index of older individuals during general anesthesia: a randomized controlled trial. Minerva Anestesiol. 2021 Jul;87(7):774-785. doi: 10.23736/S0375-9393.21.14929-6. Epub 2021 May 3. PMID 33938673
• Jonkman AH, Alcala GC, Pavlovsky B, Roca O, Spadaro S, Scaramuzzo G, Chen L, Dianti J, Sousa MLA, Sklar MC, Piraino T, Ge H, Chen GQ, Zhou JX, Li J, Goligher EC, Costa E, Mancebo J, Mauri T, Amato M, Brochard LJ; Pleural Pressure Working Group (PLUG). Lung Recruitment Assessed by Electrical Impedance Tomography (RECRUIT): A Multicenter Study of COVID-19 Acute Respiratory Distress Syndrome. Am J Re PMID 37097986
• Pei S, Wei W, Yang K, Yang Y, Pan Y, Wei J, Yao S, Xia H. Recruitment Maneuver to Reduce Postoperative Pulmonary Complications after Laparoscopic Abdominal Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Oct 1;11(19):5841. doi: 10.3390/jcm11195841. PMID 36233708
• Zhang YT, Han Y, Zhuang HJ, Feng AM, Jin L, Li XF, Yu H, Yu H. Effect of inspiratory oxygen fraction during driving pressure-guided ventilation strategy on pulmonary complications following open abdominal surgery: A randomized controlled trial. J Clin Anesth. 2024 Dec;99:111676. doi: 10.1016/j.jclinane.2024.111676. Epub 2024 Nov 6. PMID 39509739
• Hughes LM, Irwin MG, Nestor CC. Alternatives to remifentanil for the analgesic component of total intravenous anaesthesia: a narrative review. Anaesthesia. 2023 May;78(5):620-625. doi: 10.1111/anae.15952. Epub 2022 Dec 23. PMID 36562193
• Nimmo AF, Absalom AR, Bagshaw O, Biswas A, Cook TM, Costello A, Grimes S, Mulvey D, Shinde S, Whitehouse T, Wiles MD. Guidelines for the safe practice of total intravenous anaesthesia (TIVA): Joint Guidelines from the Association of Anaesthetists and the Society for Intravenous Anaesthesia. Anaesthesia. 2019 Feb;74(2):211-224. doi: 10.1111/anae.14428. Epub 2018 Oct 31. PMID 30378102

Идентификаторы

NCT: NCT07477951 · automatic lung recruitment

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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