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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pulmonary Atelectasis Lung Diseases Negative Pressure Therapy Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

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

Other

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.

Primary outcomes

Lung ultrasound score (LUSS)

Time frame: 5 min before treatment and 5 min after treatment

The 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).

Sponsors and collaborators

Lead sponsor

Jilai Xiao

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 22, 2023
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed