Ventilator Mode and Respiratory Physiology

NCT06624254 | Enrolling By Invitation

• 1 other identifier: 807319
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.

Conditions

Pulmonary Disease; Respiratory Failure; Respiratory Effort; Breathing Mechanics

Outcome Measures

Primary Outcomes (1)

• Excess tidal volume

  Exhaled tidal volume greater than 2cc/kg ideal body weight above intended or set tidal volume

  From enrollment to end of monitoring at 4 hours

Study Arms (1)

Adaptive Pressure Control

On adaptive pressure control mode with acute respiratory failure

Other: lung mechanics, respiratory drive and effort

Interventions

lung mechanics, respiratory drive and effort OTHER

Patient lung mechanics and respiratory drive and effort will be measured

Adaptive Pressure Control

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

Human subjects admitted to the intensive care unit requiring invasive mechanical ventilation for acute respiratory failure on adaptive pressure control modes of ventilation

You may qualify if:

• Admitted to ICU with acute respiratory failure
• On adaptive pressure control mode of ventilation
• Tidal volumes set between 5-8 cc/kg ideal body weight

You may not qualify if:

• Current use of neuromuscular blockade
• Inability to obtain consent from patient or surrogate decision maker
• Treating clinician refusal

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Health

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Lung Diseases; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Alex Pearce, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (1)