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Tracheal IntubationNCT06660784

Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance

An observational study of Tracheal Intubation and Extracorporeal Membrane Oxygenation, run by Zhongnan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to explore the effect of NO treatment on diaphragm function after mechanical ventilation with ECMO assistance. We expect to enroll a total of 80 patients who will receive mechanical ventilation and mechanical ventilation combined with ECMO treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nitric Oxide
How many people
80 participants
Where
1 siteChina
Study dates
16 Jan 2024to 30 Dec 2025
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients of mechanical ventilation with or without ECMO assistance in emergency ward

Who may be able to join

  • Age ≥ 18 years;
  • Tracheal intubation in our emergency department;
  • Expected survival time ≥ 72 hours;
  • Family members agree to participate and sign the informed consent form.

Who cannot join

  • Pregnant women;
  • Patients with diaphragmatic hernia or other known diaphragmatic diseases and injuries;
  • Patients with mechanical ventilation treatment within 3 months;
  • Thoracic or abdominal tumor invading the diaphragm;
  • A large amount of ascites raises the diaphragm position;
  • Upper respiratory tract malformation;
  • Trauma leading to chest collapse, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

Other trials in China

About this study

The goal of this clinical trial is to explore the effect of NO treatment on diaphragm function after mechanical ventilation with ECMO assistance. We expect to enroll a total of 80 patients who will receive mechanical ventilation and mechanical ventilation combined with ECMO treatment. Depending on the indication, they will be given NO treatment or not. In ECMO assisted mechanical ventilation + NO treatment group, the subjects will be randomly assigned to NO treatment via ventilator or membrane oxygenator. The main questions it aims to answer are:

  1. Observing the influences and potential therapeutic effects of different NO insertion methods through ventilator or membrane oxygenator on the occurrence and development of ventilator-induced diaphragm (VIDD) dysfunction during ECMO assisted mechanical ventilation.
  2. Exploring the potential key molecular mechanisms of NO treatment on the occurrence and development of VIDD after ECMO assisted mechanical ventilation.
Being tested
Nitric Oxide
Keywords
ventilator-induced diaphragm dysfunction, nitric oxide, extracorporeal membrane oxygenation, oxidative stress, endoplasmic reticulum stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitric OxideDrug

    Depending on the indication, the subjects will be given NO treatment or not. In ECMO assisted mechanical ventilation + NO treatment group, the subjects will be randomly assigned to NO treatment via ventilator or membrane oxygenator.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diaphragm function

    Continuous POCUS monitoring of diaphragm function during mechanical ventilation, including diaphragm thickness, diaphragm thickening fraction, diaphragm excursion, etc

    Measured: We starts POCUS within 1 hour (1h) after mechanical ventilation, and continuously monitoring the diaphragm function at 6h, 12h, 24h, 48h, 72h, 96h, 120h, 144h and 168h respectively. POCUS will be terminated if the patient dies.

Secondary outcomes (2)

  1. Inflammatory cytokines

    TNF - α, IL-1β , IL-6, IL-8, IL-10, etc.

    Measured: The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.

  2. Oxidative stress markers

    ROS, SOD, MDA, GSH, etc.

    Measured: The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start16 Jan 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660784
Sponsor's protocol ID
PTXM2024028
Status last verified
Sep 2024
First submitted
25 Oct 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hetz C. The unfolded protein response: controlling cell fate decisions under ER stress and beyond. Nat Rev Mol Cell Biol. 2012 Jan 18;13(2):89-102. doi: 10.1038/nrm3270.

    PubMed 22251901

  • Jiao G, Hao L, Wang M, Zhong B, Yu M, Zhao S, Wang P, Feng R, Tan S, Chen L. Upregulation of endoplasmic reticulum stress is associated with diaphragm contractile dysfunction in a rat model of sepsis. Mol Med Rep. 2017 Jan;15(1):366-374. doi: 10.3892/mmr.2016.6014. Epub 2016 Dec 9.

    PubMed 27959404

  • Maes K, Stamiris A, Thomas D, Cielen N, Smuder A, Powers SK, Leite FS, Hermans G, Decramer M, Hussain SN, Gayan-Ramirez G. Effects of controlled mechanical ventilation on sepsis-induced diaphragm dysfunction in rats. Crit Care Med. 2014 Dec;42(12):e772-82. doi: 10.1097/CCM.0000000000000685.

    PubMed 25402297

  • Liu YY, Li LF. Ventilator-induced diaphragm dysfunction in critical illness. Exp Biol Med (Maywood). 2018 Dec;243(17-18):1329-1337. doi: 10.1177/1535370218811950. Epub 2018 Nov 19.

    PubMed 30453774

  • Gallot YS, Bohnert KR. Confounding Roles of ER Stress and the Unfolded Protein Response in Skeletal Muscle Atrophy. Int J Mol Sci. 2021 Mar 4;22(5):2567. doi: 10.3390/ijms22052567.

    PubMed 33806433

  • Bohnert KR, McMillan JD, Kumar A. Emerging roles of ER stress and unfolded protein response pathways in skeletal muscle health and disease. J Cell Physiol. 2018 Jan;233(1):67-78. doi: 10.1002/jcp.25852. Epub 2017 May 16.

    PubMed 28177127

  • Afroze D, Kumar A. ER stress in skeletal muscle remodeling and myopathies. FEBS J. 2019 Jan;286(2):379-398. doi: 10.1111/febs.14358. Epub 2017 Dec 29.

    PubMed 29239106

  • Shen J, Prywes R. Dependence of site-2 protease cleavage of ATF6 on prior site-1 protease digestion is determined by the size of the luminal domain of ATF6. J Biol Chem. 2004 Oct 8;279(41):43046-51. doi: 10.1074/jbc.M408466200. Epub 2004 Aug 6.

    PubMed 15299016

  • Yoshida H, Matsui T, Yamamoto A, Okada T, Mori K. XBP1 mRNA is induced by ATF6 and spliced by IRE1 in response to ER stress to produce a highly active transcription factor. Cell. 2001 Dec 28;107(7):881-91. doi: 10.1016/s0092-8674(01)00611-0.

    PubMed 11779464

  • Haze K, Yoshida H, Yanagi H, Yura T, Mori K. Mammalian transcription factor ATF6 is synthesized as a transmembrane protein and activated by proteolysis in response to endoplasmic reticulum stress. Mol Biol Cell. 1999 Nov;10(11):3787-99. doi: 10.1091/mbc.10.11.3787.

    PubMed 10564271

  • Oida Y, Shimazawa M, Imaizumi K, Hara H. Involvement of endoplasmic reticulum stress in the neuronal death induced by transient forebrain ischemia in gerbil. Neuroscience. 2008 Jan 2;151(1):111-9. doi: 10.1016/j.neuroscience.2007.10.047. Epub 2007 Nov 13.

    PubMed 18082969

  • Tajiri S, Oyadomari S, Yano S, Morioka M, Gotoh T, Hamada JI, Ushio Y, Mori M. Ischemia-induced neuronal cell death is mediated by the endoplasmic reticulum stress pathway involving CHOP. Cell Death Differ. 2004 Apr;11(4):403-15. doi: 10.1038/sj.cdd.4401365.

    PubMed 14752508

  • Mamady H, Storey KB. Coping with the stress: expression of ATF4, ATF6, and downstream targets in organs of hibernating ground squirrels. Arch Biochem Biophys. 2008 Sep 1;477(1):77-85. doi: 10.1016/j.abb.2008.05.006. Epub 2008 May 25.

    PubMed 18541136

  • Vattem KM, Wek RC. Reinitiation involving upstream ORFs regulates ATF4 mRNA translation in mammalian cells. Proc Natl Acad Sci U S A. 2004 Aug 3;101(31):11269-74. doi: 10.1073/pnas.0400541101. Epub 2004 Jul 26.

    PubMed 15277680

  • Wek RC, Jiang HY, Anthony TG. Coping with stress: eIF2 kinases and translational control. Biochem Soc Trans. 2006 Feb;34(Pt 1):7-11. doi: 10.1042/BST20060007.

    PubMed 16246168

Questions about this trial

What is this clinical trial studying?

An observational study of Tracheal Intubation and Extracorporeal Membrane Oxygenation, run by Zhongnan Hospital 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 7 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: status not confirmed, as of the sponsor's last update on 28 Oct 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?

Results are not available in the source record.

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?

Diaphragm function (time frame: We starts POCUS within 1 hour (1h) after mechanical ventilation, and continuously monitoring the diaphragm function at 6h, 12h, 24h, 48h, 72h, 96h, 120h, 144h and 168h respectively. POCUS will be terminated if the patient dies.). 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 NCT06660784, which also lists 44 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 28 Oct 2024.

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