Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

NCT ID: NCT05902403

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-01

Brief 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).

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.

Conditions

Mechanical Ventilation Pressure High; Intensive Care Unit

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

invasive mechanical ventilation

Intervention Type: OTHER

Invasive mechanical ventilation for patients admitted to the ICU

Interventions

invasive mechanical ventilation

Invasive mechanical ventilation for patients admitted to the ICU

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Qilu Hospital of Shangdong University

Jinan, Shandong, China

Site Status: NOT_YET_RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yun Long, Dr

Role: CONTACT

ly_icu@aliyun.com

010-69152300

Longxiang Su, Dr

Role: CONTACT

slx77@163.com

010-69152301

Facility Contacts

longxiang Su

Role: primary

slx77@163.com

010-69152301

Qian Zhai

Role: primary

Xiaobo Huang

Role: primary

Yingchuan Li

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 36836113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32735841 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34696739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28244940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36788801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23215559 (View on PubMed)

Other Identifiers

RemoteVentilateView

Identifier Type: -

Identifier Source: org_study_id