Ventilator Settings and Comfort

What Ventilator Settings Are Most Comfortable for Patients With COPD or Obesity.

No studies have been done to examine whether patients with obstructive lung disease and obesity are more comfortable on some ventilator settings than on others. The purpose of the current study is to examine this question systematically.

Study Overview

• Status: Unknown
• Conditions: Obesity; Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Ventilator setting changes

Detailed Description

Methods: Demographic and physiologic data will be recorded. Investigators will begin measurements more than 60 minutes after last dose of sedative and measurements to occur when no major interventions are planned or medications are scheduled. Then patients will undergo the following ventilator settings (all of which are within ranges ordinarily employed) in random order for 3 minutes of each setting (pressures measured midway i.e. 1.5 minutes - at each interval to ensure safety; stopped if static airway pressure>30 cmH2O):

1. Assist control

   1. Tidal volumes of 6 ml/kg, 8 ml/kg and 10 ml/kg
   2. Flow regimes: constant (CF) and decelerating (dec) at 40, 60 and 80 L/min;
2. Pressure support (PS) 0, 10 and 20 cmH2O with PEEP=5 cmH2O

Patients will be randomized to receive the following in either forward or reverse order: CF60L/min in 6 then 8 then 10 ml/kg; then at 8 ml/kg CF40, Dec40, Dec60, CF60, CF80, Dec80; then PS=0, 10, 20 cmH2O.

In the last 30 second of each setting, patients will be asked to indicate their level of comfort (1-10 in increasing comfort) using a visual analog Borg Score (when they can see/write) or to indicate on their fingers when they cannot write.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Recruiting
      • Bridgeport Hospital
      • Contact: Constantine Manthous, MD; Phone Number: 203-384-4581; Email: pcmant@bpthosp.org
      • Principal Investigator: Constantine Manthous, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (>18 y) admitted to the MICU of Bridgeport Hospital on mechanical ventilation for:

  • Exacerbation of COPD (smoking history>20 pkyrs AND chest radiographic or function abnormalities supportive of the diagnosis); OR
  • Body mass index>40 kg/m2 and acute on chronic hypercapnic respiratory failure.
• Patients must be awake, not have received narcotics for more than 2 hours and possess capacity to consent themselves.
• Patients must have recovered sufficiently from their acute illness to be candidates for weaning per hospital protocol i.e. not in shock, no pressors and PaO2:FiO2>120.

Exclusion Criteria:

• Patients extubated for comfort care only.
• Patients with successful weaning trial that otherwise clinically requires extubation.
• Patients with unresolved pneumonia, unresolved congestive heart failure, neuromuscular disease or kyphoscoliosis-related respiratory failure will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' comfort	Borg score of patients' dyspnea	40 minutes

Collaborators and Investigators

• Sponsor: Bridgeport Hospital
• Investigators: Principal Investigator: Constantine Manthous, MD, Bridgeport Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Bpthosp11001