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Status unknownNCT05902403Updated Jun 15, 2023

Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

An observational study in Mechanical Ventilation Pressure High and Intensive Care Unit, sponsored by Peking Union Medical College Hospital. Status unknown at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study summary

This multicentric prospective clinical practice study aims at evaluating risk factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma and ICU length of stay in patients with elevated initial mean airway pressure based on a remote ventilation monitoring system which records venlitor input and output data (including waveforms).

Read the detailed description

Brief Background:

Evidence has accumulated that protective lung ventilation and the patient-ventilator interaction are related to the outcome of patients with lung injury. While most current studies focus on the static parameters and their association with outcomes, dynamic ventilation parameters may provide a more comprehensive assessment than static ones. Time-varying features of ventilator parameters should be paid more attention. Recently, we have developed a remote mechanical ventilation visualization network system (RemoteVentilateView) and, simultaneously, a related automatic recognition algorithm for different types of patient-ventilator asynchrony. This system enables ventilation data fully used. Our main focus is on patients who have an average airway pressure no less than 10 cmH2O upon admission to the ICU. This population has a higher ventilation intensity and may be more at risk of ventilator-induce lung injury than the average ICU patients. We aims to identify risks factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma in this specific population.

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Conditions studied

  • Mechanical Ventilation Pressure High
  • Intensive Care Unit
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In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study enrolls patients admitted to ICU needing intubation and mechanical ventilation with elevated initial mean airway pressure.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients receiving invasive mechanical ventilation, an average mean airway pressure ≥10 cmH2O for 6 consecutive hours within the first 24 hours of ICU admission.

Exclusion criteria

Exclusion Criteria:

  • Currently receiving or expected to receive ECMO treatment within 24 hours;
  • Glasgow Coma Scale (GCS) score less than 8 due to cardiac arrest, traumatic brain injury, or acute stroke;
  • Requiring invasive mechanical ventilation due to neuromuscular diseases;
  • Exceeding 24 hours from ICU admission to connection to the remote monitoring system.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • Elevated Initial Mean Airway Pressure

    Patients recieving invasive mechanical ventilation with mean airway pressure no less than 10 centimeter of water within the first 24 hours on ICU admission.

    Other: invasive mechanical ventilation

Interventions

  • Otherinvasive mechanical ventilation

    Invasive mechanical ventilation for patients admitted to the ICU

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What researchers measure

Primary outcomes

  1. liberation from MV at day 7

    liberation from MV was defined as no need for MV at least 24 consecutive hours.

    Time frame: 7 days

Secondary outcomes

  1. Duration of mechanical ventilation and 28 days ventilator free days

    Ventilator-free days (VFDs) were defined as a time frame of 28 days from intubation. For intubated patients, in caseof reintubation within 28 days, VFDs were counted from the last successful extubation. The use of non-invasive ventilation (NIV) after extubation was not considered as a ventilation period. Finally, zero VFDs were assigned to 28-day non-survivors, regardless of their intubation status.

    Time frame: 28 days

  2. Barotrauma

    We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between inclusion and 7 days, except those judged to be clearly caused by invasive procedures.

    Time frame: 7 days

  3. 28-day Mortality

    Time frame: 28 days

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Study locations

1 of 4 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    Recruiting
  • Qilu Hospital of Shangdong University
    Jinan, Shandong, China
    • Qian Zhai · Contact
    Not yet recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
    • Xiaobo Huang · Contact
    Not yet recruiting
  • Shanghai Tenth People's Hospital
    Shanghai, China
    • Yingchuan Li · Contact
    Not yet recruiting
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References and documents

Publications

  • Su L, Lan Y, Chi Y, Cai F, Bai Z, Liu X, Huang X, Zhang S, Long Y. Establishment and Application of a Patient-Ventilator Asynchrony Remote Network Platform for ICU Mechanical Ventilation: A Retrospective Study. J Clin Med. 2023 Feb 16;12(4):1570. doi: 10.3390/jcm12041570. PubMed 36836113 ↗
  • Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28. PubMed 32735841 ↗
  • Chi Y, Zhang Q, Yuan S, Zhao Z, Long Y, He H. Twenty-four-hour mechanical power variation rate is associated with mortality among critically ill patients with acute respiratory failure: a retrospective cohort study. BMC Pulm Med. 2021 Oct 25;21(1):331. doi: 10.1186/s12890-021-01691-4. PubMed 34696739 ↗
  • Long Y, Su L, Zhang Q, Zhou X, Wang H, Cui N, Chai W, Wang X, Rui X, Liu D. Elevated Mean Airway Pressure and Central Venous Pressure in the First Day of Mechanical Ventilation Indicated Poor Outcome. Crit Care Med. 2017 May;45(5):e485-e492. doi: 10.1097/CCM.0000000000002290. PubMed 28244940 ↗
  • Su L, Pan P, Liu D, Long Y. Mean airway pressure has the potential to become the core pressure indicator of mechanical ventilation: Raising to the front from behind the clinical scenes. J Intensive Med. 2021 May 28;1(2):96-98. doi: 10.1016/j.jointm.2021.04.002. eCollection 2021 Oct. PubMed 36788801 ↗
  • McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available. PubMed 23215559 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05902403
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Jun 1, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jun 15, 2023

Study contacts

Yun Long, Dr
Contact
ly_icu@aliyun.com
010-69152300
Longxiang Su, Dr
Contact
slx77@163.com
010-69152301

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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