Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

NCT05902403 | Unknown

• 1 other identifier: RemoteVentilateView
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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).

Conditions

Mechanical Ventilation Pressure High; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• liberation from MV at day 7

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

  7 days

Secondary Outcomes (3)

• Duration of mechanical ventilation and 28 days ventilator free days

  28 days

• Barotrauma

  7 days

• 28-day Mortality

  28 days

Study Arms (1)

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

invasive mechanical ventilation OTHER

Invasive mechanical ventilation for patients admitted to the ICU

Elevated Initial Mean Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Qilu Hospital of Shangdong University

Jinan, Shandong, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital

Shanghai, China

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 36836113 BACKGROUND

• 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.

  PMID: 32735841 BACKGROUND

• 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.

  PMID: 34696739 BACKGROUND

• 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.

  PMID: 28244940 BACKGROUND

• 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.

  PMID: 36788801 BACKGROUND

• 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.

  PMID: 23215559 BACKGROUND

Central Study Contacts

Yun Long, Dr

CONTACT

010-69152300; ly_icu@aliyun.com

Longxiang Su, Dr

CONTACT

010-69152301; slx77@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 15, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CN (4)