Back to resultsEvaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis
Primary Purpose
Postoperative Pulmonary Atelectasis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
novel recruitment maneuver therapy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pulmonary Atelectasis
Eligibility Criteria
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
Sites / Locations
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
novel recruitment maneuver therapy
control group
Arm Description
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.
The automatic ventilation mode (PSV or CPAP) is used during mechanical ventilation, with the pressure support set to 0 cmH2O and the positive end-expiratory pressure set to 30 to 45 cmH2O for 30 to 40s, and then adjusted to the previous breathing pattern.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06049173
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jilai Xiao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pulmonary Atelectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
novel recruitment maneuver therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The automatic ventilation mode (PSV or CPAP) is used during mechanical ventilation, with the pressure support set to 0 cmH2O and the positive end-expiratory pressure set to 30 to 45 cmH2O for 30 to 40s, and then adjusted to the previous breathing pattern.
Intervention Type
Other
Intervention Name(s)
novel recruitment maneuver therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary ultrasound
Description
Pulmonary ultrasound score (LUS score) , minimum value 0 to maximum value 36. The higher the score, the more severe the loss of lung ventilation
Time Frame
1 hour before treatment and 1 hour after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Nanjing
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25604600
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.
Results Reference
background
PubMed Identifier
35377472
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.
Results Reference
background
PubMed Identifier
32653270
Citation
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.
Results Reference
background
PubMed Identifier
28331959
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.
Results Reference
background
PubMed Identifier
16096751
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.
Results Reference
background
PubMed Identifier
33336263
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.
Results Reference
background
PubMed Identifier
29596015
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.
Results Reference
background
PubMed Identifier
34110233
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.
Results Reference
background
Learn more about this trial
Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis
We'll reach out to this number within 24 hrs