Postoperative Pulmonary AtelectasisNCT06049173
Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis
A study testing Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver and stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver in people with Postoperative Pulmonary Atelectasis and Negative Pressure Therapy, run by Jilai Xiao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pulmonary Atelectasis, Negative Pressure Therapy
- What is being tested?
- Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver and stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery
- 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.
- Being tested
- Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver, stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver
- Keywords
- Negative extra-abdominal pressure (NEXAP), lung recruitment maneuver, postoperative atelectasis, cardiac surgery
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuverDevice
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 maneuverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NEXAP group | Experimental | 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. Receives: Device: Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver |
| PEEP group | Active comparator | 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. Receives: Other: stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score (LUSS)
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).
Measured: 5 min before treatment and 5 min after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start10 Sep 2023
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jilai Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jilai Xiao, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Jilai Xiao, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049173
- Sponsor's protocol ID
- KY20230829-04
- Status last verified
- Dec 2024
- First submitted
- 10 Sep 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25604600Keogh 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.
PubMed 35377472Bruni 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.
PubMed 32653270Gattinoni 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.
PubMed 28331959Nielsen 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.
PubMed 16096751Scharffenberg 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.
PubMed 33336263Yoshida 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.
PubMed 29596015Rohrs 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.
PubMed 34110233Xiong S, Xiao J, Hong L, Shen X, Tao H, Jin R, Xu Q, Su L, Zhang C. Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver versus standard lung recruitment maneuver in the treatment of postoperative atelectasis after cardiac surgery: A single-center randomized controlled trial. J Crit Care. 2025 Oct;89:155124. doi: 10.1016/j.jcrc.2025.155124. Epub 2025 May 22.
PubMed 40409053
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06049173
- Acronym / sponsor ID
- KY20230829-04
- Keywords
- Negative extra-abdominal pressure (NEXAP), lung recruitment maneuver, postoperative atelectasis, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Jilai XiaoUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEXAP group | Experimental | Device: Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuverThe 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 | Active comparator | Other: stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuverThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuverThe 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. | Device | NEXAP group |
| stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuverThe 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. | Other | PEEP group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 25604600Ubben 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.
- Background: PubMed 35377472Keogh 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.
- Background: PubMed 32653270Bruni 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.
- Background: PubMed 28331959Gattinoni 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.
- Background: PubMed 16096751Nielsen 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.
- Background: PubMed 33336263Scharffenberg 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.
- Background: PubMed 29596015Yoshida 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.
- Background: PubMed 34110233Rohrs 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.
- Derived from this study: PubMed 40409053Xiong S, Xiao J, Hong L, Shen X, Tao H, Jin R, Xu Q, Su L, Zhang C. Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver versus standard lung recruitment maneuver in the treatment of postoperative atelectasis after cardiac surgery: A single-center randomized controlled trial. J Crit Care. 2025 Oct;89:155124. doi: 10.1016/j.jcrc.2025.155124. Epub 2025 May 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jilai Xiao study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver and stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver in people with Postoperative Pulmonary Atelectasis and Negative Pressure Therapy, run by Jilai Xiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound score (LUSS) (time frame: 5 min before treatment and 5 min after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049173, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.