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Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis

Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06049173
Enrollment
77
Registered
2023-09-22
Start date
2023-09-10
Completion date
2024-04-20
Last updated
2024-12-04

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

Conditions

Negative Pressure Therapy, Postoperative Pulmonary Atelectasis

Keywords

Negative extra-abdominal pressure (NEXAP), lung recruitment maneuver, postoperative atelectasis, cardiac surgery

Brief summary

1. Oxygenation index and bedside ultrasound would be used to evaluate the therapeutic effect of novel recruitment maneuver therapy in the patients with pulmonary atelectasis after cardiac surgery. 2. To establish a new therapy strategy for pulmonary atelectasis after cardiac surgery and to evaluate its effectiveness and safety for the cardiac patients complicated with postoperative pulmonary atelectasis.

Interventions

DEVICENegative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver

The ventilator mode was changed from SIMV to PSV before LRM. After that, the abdominal pressure cardiopulmonary resuscitation (CPR-LW100) instrument was adopted and adsorbed on the epigastrium of patients. The LRM was performed by pulling up (tension of 20-30 kg) and compressing downward (tension\<10 kg) alternately on the abdomen of the patients with a frequency of 12 times per minute to support and maintain breathing. The whole LRM procedure lasted for 3 minutes in total. After LRM, the ventilator mode was changed to its baseline settings.

OTHERstepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver

The ventilator mode was changed from SIMV to PSV before LRM. After that, PEEP was increased gradually (every 3-5cmH2O per 30s) from baseline (5-8 cmH2O) to 20cmH2O. The PEEP level was maintained at 20cmH2O for 60s, followed by decrements to baseline PEEP (every 3-5cmH2O per 30s). After LRM, the ventilator was changed to the baseline settings.

Sponsors

Jilai Xiao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Age ≥ 18 years * Underwent cardiac surgery with CPB * Patients with lung ultrasound evidence of atelectasis after surgery * Agree to participate in this study by themselves or their family member.

Exclusion criteria

* Vasoactive-inotropic score (VIS)\>20 * Patients who were not suitable for using abdominal CPR compression-decompression instrument: bleeding from abdominal organs, abdominal aortic aneurysm, large abdominal tumor, intra-abdominal hypertension, etc * Hemothorax or large pleural effusion confirmed by ultrasonography/X-ray * Pneumothorax or air leak confirmed by ultrasonography/X-ray * Considered by other researchers to be unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frameDescription
Lung ultrasound score (LUSS)5 min before treatment and 5 min after treatmentThe thorax was divided by the anterior axillary line, the posterior axillary line, and a horizontal line beneath the nipple. The intercostal spaces of each of the 12 areas were scanned and analyzed . Aeration loss was assessed by calculating the modified lung ultrasound score (LUSS), which showed sufficient sensitivity to detect aeration loss. Two lung ultrasound examiners provided scores for each area after simultaneous examination of the lung scan. LUSS was then calculated globally (LUSStot, as the sum of the 12 regions score, ranging from 0 to 36), and regionally (LUSSp, posterior, LUSSa, anterior and LUSSl, lateral regions).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026