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

Postoperative Pulmonary Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049173
• Other study ID #: KY20230829-04
• Status: Completed
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• chest radiograph and bedside ultrasound indicated atelectasis After cardiac surgery and cardiopulmonary bypass Circulation is basically stable (VIS score <20)

Exclusion Criteria:

• Presence of abdominal trauma Have a history of severe gastrointestinal disease or gastrointestinal surgery Bring into IABP(Intra-Aortic Balloon Pump)or ECMO(Extracorporeal membrane oxygenation)after operation Other conditions determined by the investigator to be unsuitable for participation in this study

Related Conditions & MeSH terms

• Postoperative Pulmonary Atelectasis
• Pulmonary Atelectasis

Intervention

Other:
• novel recruitment maneuver therapy
The use of abdominal compression cardiopulmonary resuscitation apparatus for new recruitment maneuver therapy: the use of autonomous ventilation mode (PSV or CPAP) during mechanical ventilation, followed by abdominal compression recruitment maneuver therapy, the number of times of each compression is 5-10, each time the duration of 30 to 40s, and then adjust to the previous breathing pattern.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Jilai Xiao

Country where clinical trial is conducted

China, 

References & Publications (8)

Bruni A, Garofalo E, Pasin L, Serraino GF, Cammarota G, Longhini F, Landoni G, Lembo R, Mastroroberto P, Navalesi P; MaGIC (Magna Graecia Intensive care and Cardiac surgery) Group. Diaphragmatic Dysfunction After Elective Cardiac Surgery: A Prospective Observational Study. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3336-3344. doi: 10.1053/j.jvca.2020.06.038. Epub 2020 Jun 17. — View Citation

Gattinoni L, Tonetti T, Quintel M. Intensive care medicine in 2050: ventilator-induced lung injury. Intensive Care Med. 2018 Jan;44(1):76-78. doi: 10.1007/s00134-017-4770-8. Epub 2017 Mar 22. No abstract available. — View Citation

Keogh C, Saavedra F, Dubo S, Aqueveque P, Ortega P, Gomez B, Germany E, Pinto D, Osorio R, Pastene F, Poulton A, Jarvis J, Andrews B, FitzGerald JJ. Non-invasive phrenic nerve stimulation to avoid ventilator-induced diaphragm dysfunction in critical care. Artif Organs. 2022 Oct;46(10):1988-1997. doi: 10.1111/aor.14244. Epub 2022 Apr 12. — View Citation

Nielsen J, Ostergaard M, Kjaergaard J, Tingleff J, Berthelsen PG, Nygard E, Larsson A. Lung recruitment maneuver depresses central hemodynamics in patients following cardiac surgery. Intensive Care Med. 2005 Sep;31(9):1189-94. doi: 10.1007/s00134-005-2732-z. Epub 2005 Aug 12. — View Citation

Rohrs EC, Bassi TG, Fernandez KC, Ornowska M, Nicholas M, Wittmann JC, Reynolds SC. Diaphragm neurostimulation during mechanical ventilation reduces atelectasis and transpulmonary plateau pressure, preserving lung homogeneity and [Formula: see text]/[Formula: see text]. J Appl Physiol (1985). 2021 Jul 1;131(1):290-301. doi: 10.1152/japplphysiol.00119.2021. Epub 2021 Jun 10. — View Citation

Scharffenberg M, Wittenstein J, Herzog M, Tauer S, Vivona L, Theilen R, Bluth T, Kiss T, Koch T, Fiorentino G, de Abreu MG, Huhle R. Continuous external negative pressure improves oxygenation and respiratory mechanics in Experimental Lung Injury in Pigs - A pilot proof-of-concept trial. Intensive Care Med Exp. 2020 Dec 18;8(Suppl 1):49. doi: 10.1186/s40635-020-00315-1. — View Citation

Ubben JF, Lance MD, Buhre WF, Schreiber JU. Clinical strategies to prevent pulmonary complications in cardiac surgery: an overview. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):481-90. doi: 10.1053/j.jvca.2014.09.020. Epub 2015 Jan 17. No abstract available. — View Citation

Yoshida T, Engelberts D, Otulakowski G, Katira B, Ferguson ND, Brochard L, Amato MBP, Kavanagh BP. Continuous negative abdominal pressure: mechanism of action and comparison with prone position. J Appl Physiol (1985). 2018 Jul 1;125(1):107-116. doi: 10.1152/japplphysiol.01125.2017. Epub 2018 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary ultrasound	Pulmonary ultrasound score (LUS score) , minimum value 0 to maximum value 36. The higher the score, the more severe the loss of lung ventilation	1 hour before treatment and 1 hour after treatment