Weaning From Mechanical Ventilation Using Permissive Hypercarbia

NCT00357929 | Terminated

• 1 other identifier: 23214
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients receiving mechanical ventilation have difficulty weaning off the ventilator because of physiological factors such as pre-existing lung disease, respiratory distress syndrome, and trauma among others. Allowing patients to become hypercarbic (increased blood bicarbonate level) may make it easier for these patients to be taken off the ventilator and resume breathing on their own.

Conditions

Respiration, Artificial; Respiratory Distress Syndrome, Adult

Keywords

permissive hypercarbia; weaning from mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Time for weaning from positive pressure support mechanical ventilation

Secondary Outcomes (1)

• Percentage of subjects/group successfully weaned within seven days of trial participation

Interventions

Permissive hypercarbia PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Adult (\> 18 yo) patients in the intensive care units at the Hershey Medical Center who are on mechanical ventilation
• and whose clinical course permits weaning from mechanical ventilation
• and are felt to have risk factors for difficult weaning. (Risk factors will include patients with rib fractures, pulmonary contusions, obesity (BMI \>30), or history of COPD or other significant lung disease.)
• all patients will have failed (rapid shallow breathing index \>105) a 30 minute spontaneous breathing test.

You may not qualify if:

• Overt signs of sepsis including: a temperature \> 38.5F, white blood cell count \> 14000, systolic blood pressure \< 100 mmHg,
• intracranial hypertension (ICP \> 18 or based upon clinical exam and/or history),
• or pulmonary hypertension (by history or PAsys \> 40 mmHg).
• or history of recent(past 6 mos)MI

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Study Officials

• Kane M High, MD

  Penn State University, College of Medicine, Penn State Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 28, 2006
• Study Start: August 1, 2006
• Primary Completion: June 14, 2007
• Study Completion: June 14, 2007
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

US (1)