Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis
NCT ID: NCT06049173
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2023-09-10
2024-04-20
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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NEXAP group
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.
Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver
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.
PEEP group
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.
stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver
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.
Interventions
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Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Jilai Xiao
OTHER
Responsible Party
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Jilai Xiao
associate chief physician
Principal Investigators
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Jilai Xiao
Role: STUDY_DIRECTOR
Nanjing First Hospital, Nanjing Medical University
Locations
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Nanjing First Hospital
Nanjing, Nanjing, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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 P a O 2 / F I O 2 . J Appl Physiol (1985). 2021 Jul 1;131(1):290-301. doi: 10.1152/japplphysiol.00119.2021. Epub 2021 Jun 10.
Other Identifiers
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KY20230829-04
Identifier Type: -
Identifier Source: org_study_id