The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications

NCT07477951 | Not Yet Recruiting DMC

• 1 other identifier: automatic lung recruitment
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lung Injury

Keywords

Automated recruitment maneuver (Auto-RM); Total Intravenous Anesthesia (TIVA); postoperative pulmonary complications (PPCs); acute lung injury (ALI)

Outcome Measures

Primary Outcomes (1)

• oxygenation index (PaO₂/FiO₂ ratio) at 30 minutes after extubation

  Arterial blood samples were collected for blood gas analysis

  30 minutes after extubation

Secondary Outcomes (8)

• extubation time, duration of PACU stay after anesthesia

  until actual discharge from the PACU

• Incidence of postoperative shivering

  Day 1

• The incidence of pulmonary complications occurring within the first 7 days following surgery

  up to 7 days

• Incidence of postoperative hypoxemia (SpO₂ < 94%) within 24 hours after surgery

  Day 1

• QoR-15 (15-item Quality of Recovery) scores on postoperative days 1, 2, and 3

  Days 1, 2, and 3

Study Arms (2)

conventional ventilation group

NO INTERVENTION

Total Intravenous Anesthesia (TIVA) + Volume-Controlled Ventilation (VCV) The procedure was performed with total intravenous anesthesia (TIVA) combined with volume-controlled ventilation (VCV). The settings for the lung-protective ventilation strategy were as follows: tidal volume was maintained at 6-8 mL/kg predicted body weight (PBW) (calculated as: 50 + 0.91 × \[height (cm) - 152.4\] for males; 45.5 + 0.91 × \[height (cm) - 152.4\] for females). The inspiratory-to-expiratory ratio was set at 1:2, and a positive end-expiratory pressure (PEEP) of 5 cmH₂O was applied intraoperatively. The ventilation rate was adjusted according to intraoperative end-tidal carbon dioxide (PetCO₂) to maintain PetCO₂ within the range of 35-50 mmHg.

Automated recruitment maneuver (Auto-RM) group

EXPERIMENTAL

Automated recruitment maneuvers (Auto-RM) were performed using the HuaSheng Lavender anesthesia machine at 10 min after intubation/laryngeal mask insertion and again 10 min before the end of surgery, in addition to TIVA with VCV. Using the PEEP incremental method in PCV mode (respiratory rate 10/min, I:E 1:1, driving pressure 10-15 cmH₂O), PEEP was increased by 5 cmH₂O every 30 s from baseline until peak pressure reached 40 cmH₂O. PEEP was then gradually decreased, and the level corresponding to the minimum driving pressure (DP = Pplat - PEEP) was recorded and maintained. Other ventilator settings were identical to the control group.

Device: Automated recruitment maneuver (Auto-RM)

Interventions

Automated recruitment maneuver (Auto-RM) DEVICE

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 inspiratory-to-expiratory ratio of 1:1, and a controlled pressure maintained at 10-15 cmH₂O. Starting from the baseline PEEP level, PEEP was increased by 5 cmH₂O every 30 seconds until peak pressure reached 40 cmH₂O. Subsequently, PEEP was gradually decreased, and the PEEP level corresponding to the minimum driving pressure (DP = plateau pressure - PEEP) during the recruitment process was recorded and maintained intraoperatively.

Automated recruitment maneuver (Auto-RM) group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yongtao Sun: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

Jinan, Shandong, 250014, China

Location

Related Publications (18)

• 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, Kucur E, Mugarra A, Soro M, Garcia L, Sastre JA, Aguirre P, Salazar CJ, Ramos MC, Morocho DR, Trespalacios R, Ezequiel-Fernandez F, Lamanna A, Pia Cantatore L, Laforgia D, Bellas S, Lopez C, Navarro-Ripoll R, Martinez S, Vallverdu J, Jacas A, Yepes-Temino MJ, Belda FJ, Tusman G, Suarez-Sipmann F, Villar J; iPROVE-OLV Research Network Group. Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2024 Mar;12(3):195-206. doi: 10.1016/S2213-2600(23)00346-6. Epub 2023 Dec 5.

  PMID: 38065200 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Respir Crit Care Med. 2023 Jul 1;208(1):25-38. doi: 10.1164/rccm.202212-2300OC.

  PMID: 37097986 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.

  PMID: 31587835 BACKGROUND

• Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8. doi: 10.1016/s0300-9572(98)00095-1.

  PMID: 9863573 BACKGROUND

• Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.

  PMID: 26120769 BACKGROUND

• Campos LI, Mansfield D, Smith A, Kohli H, Sun D, Espinosa MH, Dy V. Carbon dioxide volume and intra-abdominal pressure determination before the creation of a pneumoperitoneum. Surg Laparosc Endosc. 1995 Apr;5(2):100-4.

  PMID: 7773453 BACKGROUND

• Takiguchi S, Fujiwara Y, Yamasaki M, Miyata H, Nakajima K, Sekimoto M, Mori M, Doki Y. Laparoscopy-assisted distal gastrectomy versus open distal gastrectomy. A prospective randomized single-blind study. World J Surg. 2013 Oct;37(10):2379-86. doi: 10.1007/s00268-013-2121-7.

  PMID: 23783252 BACKGROUND

• Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

  PMID: 20160637 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• 江洪洋,樊世文,刘铁龙,等.个体化PEEP联合定期肺复张对行腹腔镜结直肠癌根治术老年患者术后肺不张的影响[J].天津医药,2024,52(02):182-187.

  BACKGROUND

• Spraider P, Abram J, Wally D, Bernardi D, Augustin F, Hell T, Tscholl P, Dejaco H. Low versus High Fraction of Inspired Oxygen During Lung Separation in Thoracic Surgery: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2025 Jul;39(7):1746-1754. doi: 10.1053/j.jvca.2025.03.031. Epub 2025 Mar 20.

  PMID: 40210503 BACKGROUND

• 刘宇锋,赵智慧.不同吸入氧浓度对腹腔镜结直肠癌根治术老年患者氧合的影响[J].内蒙古医学杂志,2023,55(01):18-20+24.

  BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Liu Mengjie, Doctoral Degree

CONTACT

0531-89268535; liumengjie31@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: This is a prospective, single-center, randomized controlled trial with a parallel-group design. Eligible participants will be randomly assigned in a 1:1 ratio to either the automated recruitment maneuver (Auto-RM) group or the conventional ventilation (control) group using a computer-generated random sequence with a block size of 4. The randomization sequence will be generated by an independent statistician not involved in participant enrollment or intervention. Outcome assessors will be blinded to group allocation, while the attending anesthesiologists cannot be blinded due to the nature of the intervention.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)