Clinical trial NCT06049173: Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis
Official title: Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Atelectasis
Negative Pressure Therapy
Keywords: Negative extra-abdominal pressure (NEXAP)
lung recruitment maneuver
postoperative atelectasis
cardiac surgery
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lung ultrasound score (LUSS)
timeFrame: 5 min before treatment and 5 min after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Nanjing
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Jilai Xiao
role: STUDY_DIRECTOR
References:
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