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Acute Lung InjurylungNCT07477951

The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications

A study testing Automated recruitment maneuver (Auto-RM) in people with Acute Lung Injury, run by Yongtao Sun at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acute Lung Injury
What is being tested?
Automated recruitment maneuver (Auto-RM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
1 Apr 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liu Mengjie, Doctoral Degree contact

0531-89268535 ext. +8615628920681

liumengjie31@163.com

China1 site

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

    Jinan, Shandong, 250014

    Liu Mengjie, Doctoral Degree, 0531-89268535 ext. +8615628920681, liumengjie31@163.com

Other trials in China

About this study

Official title: 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

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.

Read more

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.

Being tested
Automated recruitment maneuver (Auto-RM)
Keywords
Automated recruitment maneuver (Auto-RM), Total Intravenous Anesthesia (TIVA), postoperative pulmonary complications (PPCs), acute lung injury (ALI)
Medical subject headings
Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07477951
Study groupRoleWhat they receive
conventional ventilation groupNo interventionTotal 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) groupExperimentalAutomated 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.
Receives: Device: Automated recruitment maneuver (Auto-RM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Arterial blood samples were collected for blood gas analysis

    Measured: 30 minutes after extubation

Secondary outcomes (8)

  1. extubation time, duration of PACU stay after anesthesia

    The time interval from the end of surgery to successful tracheal extubation, and the interval from PACU admission to meeting discharge criteria and actual PACU discharge, were recorded. The former was recorded by the anesthesia nurse according to clock time, with timestamps automatically captured by the anesthesia information management system. The latter was documented by the PACU nurse, noting the specific times of admission and discharge.

    Measured: until actual discharge from the PACU

  2. Incidence of postoperative shivering

    Postoperative shivering was assessed using the Wrench grading scale (0-4). Grade 0 indicated no shivering; Grade 1 indicated piloerection, peripheral vasoconstriction, or peripheral cyanosis without visible muscle tremor; Grade 2 indicated tremor confined to a single muscle group; Grade 3 indicated tremor involving multiple muscle groups; and Grade 4 indicated generalized gross muscular activity. Shivering was considered clinically significant (event) when the Wrench grade was ≥3. If such shivering persisted for more than 3 minutes, a rescue dose of meperidine was administered.

    Measured: Day 1

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

    The occurrence of postoperative pulmonary complications (PPCs) during hospitalization, including pulmonary infection, acute respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonia, and acute respiratory distress syndrome (ARDS), was assessed by reviewing electronic medical records, imaging systems, and laboratory databases. The incidence of individual postoperative pulmonary complications (PPCs) within 7 days after surgery was recorded, including atelectasis, pneumonia, and acute respiratory distress syndrome (ARDS). Each complication was defined according to standardized criteria (e.g., for pneumonia: new lung infiltrate plus fever >38°C and leukocytosis). The occurrence of any PPC was considered an adverse outcome.

    Measured: up to 7 days

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

    Pulse oximetry monitoring was applied; the number of episodes, duration, and whether any interventions were taken were recorded.

    Measured: Day 1

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

    QoR-15 scores were assessed on postoperative days 1, 2, and 3 using the 15-item Quality of Recovery (QoR-15) scale，range: 0-150, with higher scores indicating better recovery.

    Measured: Days 1, 2, and 3

  6. all-cause mortality within 30 days after surgery

    Survival status was assessed daily during hospitalization. Patients discharged before postoperative day 30 were followed up by telephone on day 30. Deaths were verified through hospital records, death registries, or family reports.

    Measured: up to 30 days

  7. Incidence of postoperative nausea and vomiting (PONV) at 24, 48, and 72 hours after surgery

    Nausea and vomiting were graded using the following scale:

    Grade 1: Mild nausea and abdominal discomfort, but no vomiting; Grade 2: Transient vomiting, ≤1 episode; Grade 3: Vomiting requiring antiemetic therapy, ≤2 episodes; Grade 4: Vomiting refractory to antiemetic therapy, ≥3 episodes.

    Measured: Days 1, 2 and 3

  8. Postoperative NRS scores at 24, 48, and 72 hours

    Pain intensity was assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more severe pain.

    Measured: Days 1, 2 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07477951
Sponsor's protocol ID
automatic lung recruitment
Acronym
lung
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30378102

  • 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.

    PubMed 31587835

  • 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.

    PubMed 9863573

  • 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.

    PubMed 26120769

  • 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.

    PubMed 7773453

  • 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.

    PubMed 23783252

  • 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.

    PubMed 20160637

  • 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.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A study testing Automated recruitment maneuver (Auto-RM) in people with Acute Lung Injury, run by Yongtao Sun at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu Mengjie, Doctoral Degree (0531-89268535 ext. +8615628920681, liumengjie31@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oxygenation index (PaO₂/FiO₂ ratio) at 30 minutes after extubation (time frame: 30 minutes after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07477951, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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