Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure Based on a Remote Ventilation Monitoring Platform

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).

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit; Mechanical Ventilation Pressure High
• Intervention / Treatment: Other: invasive mechanical ventilation

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Yun Long, Dr; Phone Number: 010-69152300; Email: ly_icu@aliyun.com
• Study Contact Backup: Name: Longxiang Su, Dr; Phone Number: 010-69152301; Email: slx77@163.com

Study Locations

• China
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Tenth People's Hospital
    • Contact: Yingchuan Li
  • Beijing
    • Peking, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: longxiang Su; Phone Number: 010-69152301; Email: slx77@163.com
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shangdong University
      • Contact: Qian Zhai
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Xiaobo Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Invasive mechanical ventilation for patients admitted to the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liberation from MV at day 7	liberation from MV was defined as no need for MV at least 24 consecutive hours.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
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.	7 days
28-day Mortality		28 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RemoteVentilateView

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No