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

Jilai Xiao

Status: Completed

Conditions: Postoperative Pulmonary Atelectasis; Negative Pressure Therapy

Treatments: Other: stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver; Device: Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT06049173

KY20230829-04

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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77 participants in 2 patient groups

NEXAP group

Experimental group

Description:

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.

Treatment:

Device: Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver

PEEP group

Active Comparator group

Description:

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.

Treatment:

Other: stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver