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Effects of Positive End-Expiratory Pressure Levels on Lung Recruitment Duration and Hemodynamics After Alveolar Recruitment Maneuver: A Randomized Clinical Trial

Effects of Positive End-Expiratory Pressure Levels on Lung Recruitment Duration and Hemodynamics After Alveolar Recruitment Maneuver: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07161466
Enrollment
101
Registered
2025-09-08
Start date
2025-08-30
Completion date
2025-11-30
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Recruitment Maneuver, Dynamic Lung Compliance

Brief summary

During general anesthesia surgery, the role of positive end-expiratory pressure (PEEP) in mechanical ventilation remains uncertain. Pressure levels above 0 cm H₂O can prevent postoperative pulmonary complications but may also cause intraoperative circulatory depression and lung injury due to overdistension. Using very low levels of PEEP may lead to atelectasis. However, high levels of PEEP can not only trigger complications such as intraoperative circulatory depression but also promote hyperinflation. Positive end-expiratory pressure (PEEP) is required to prevent atelectasis during lung-protective ventilation, and different levels of PEEP exhibit varying physiological and clinical effects when used alone or in combination with alveolar recruitment maneuvers (ARM). Alveolar recruitment maneuvers (ARM) are used to open atelectatic lung parenchyma, but the duration of their benefits has not been clearly determined. This study aims to determine the effectiveness of different PEEP levels after ARM in general anesthesia surgery, the duration of their time-dependent responses, and their hemodynamic effects, providing a reference for how often recruitment maneuvers should be performed during general anesthesia and further refining the specific details of lung-protective ventilation strategies.

Interventions

BEHAVIORALlung recruitment maneuvre; PEEP

After the patient enters the operating room, routine monitoring of ECG, non-invasive blood pressure, and SpO₂ is performed. Local anesthesia is used for radial artery puncture and catheterization to monitor invasive blood pressure. After 3 minutes of pre-oxygenation, tracheal intubation is performed with the following ventilation parameters: VT 6-8 ml/kg, FiO₂ 60%, RR 15 breaths/min, I/E 1:2, and PEEP 4 cmH₂O. Ten minutes after the establishment of pneumoperitoneum during surgery, baseline levels of respiratory mechanical parameters and hemodynamic variables are recorded. Subsequently, alveolar recruitment is performed at a pressure of 30 cmH₂O for 30 seconds. Immediately after recruitment, the PEEP level is adjusted according to the group. The changes in respiratory mechanics parameters and hemodynamic variables after recruitment are recorded. After the outcome indicators recover to the new baseline level, the PEEP is readjusted to 4 cmH₂O.

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ASA physical status classification: Ⅰ or Ⅱ or Ⅲ * Adults aged 18 to 80 years, regardless of gender. * Patients undergoing elective laparoscopic colorectal cancer surgery under general anesthesia. * Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.

Exclusion criteria

* Recent thoracic surgery; radiographic evidence of pneumothorax, emphysema, or pulmonary bullae; * Pulmonary diseases: asthma or severe obstructive ventilatory dysfunction; preoperative pulse oxygen saturation (SpO2) \< 90% on room air or \< 95% with supplemental oxygen; contraindications to ARMs (e.g., intracranial hypertension, hypovolemic shock, or right heart failure); * severe cardiac disease (NYHA class III/IV, acute coronary syndrome, sustained ventricular tachycardia); concurrent participation in another trial; or refusal to provide informed consent

Design outcomes

Primary

MeasureTime frame
the duration of improvement in lung complianceduring the surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026