The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

NCT01003730 | Terminated

• 1 other identifier: 0120080132
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to determine if there is a way the investigators can improve the techniques that they use to assist patients with their breathing during surgery. The majority of surgeries require patients to concurrently undergo general anesthesia. This usually includes a breathing tube and a machine that breathes for the patient during the duration of the surgery. The doctors would like to investigate the effects of this type of anesthesia to healthy adult patients and whether they can improve the way they give general anesthesia to patients. The investigators plan to ask approximately 200 patients to participate. If the patients decide to participate in the study,some additions will be made to the standard anesthetic care they receive. The patients will additionally be monitored for adequate oxygenation in their blood as well as level of inflammation in their blood and lungs. The patients' breathing tube will be bathed with warm normal saline and suctioned twice during the operation. When these procedures are done the patients will be asleep and not be aware of what is happening.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Intraoperative protective ventilation strategies

Outcome Measures

Primary Outcomes (1)

• cytokine levels in serum and bronchial aspirate

  during the operative procedure

Secondary Outcomes (2)

• arterial blood gases

  during the operative procedure

• subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission

  wothin 30 days of surgery

Study Arms (3)

1

ACTIVE COMPARATOR

High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O

Other: Ventilator settings

2

ACTIVE COMPARATOR

Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)

Other: Ventilator settings

3

ACTIVE COMPARATOR

low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)

Other: Ventilator settings

Interventions

Ventilator settings OTHER

Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.

1; 2; 3

Eligibility Criteria

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

You may qualify if:

• Elective surgery under general anesthesia expected to take 4 hours or more positioned supine for surgery

You may not qualify if:

• Subjects who have HIV or who have had Radiation or chemotherapy for cancer
• Subjects undergoing surgery on chest or lings
• Subjects who have obstructive sleep apnea (OSA), asthma, tuberculosis, chronic obstructive pulmonary disease

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ/University Hospital

Newark, New Jersey, 07101, United States

Location

Related Publications (2)

• Wrigge H, Zinserling J, Stuber F, von Spiegel T, Hering R, Wetegrove S, Hoeft A, Putensen C. Effects of mechanical ventilation on release of cytokines into systemic circulation in patients with normal pulmonary function. Anesthesiology. 2000 Dec;93(6):1413-7. doi: 10.1097/00000542-200012000-00012.

  PMID: 11149435 BACKGROUND

• Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Dromann D, Welz A, Uhlig S, Putensen C. Mechanical ventilation strategies and inflammatory responses to cardiac surgery: a prospective randomized clinical trial. Intensive Care Med. 2005 Oct;31(10):1379-87. doi: 10.1007/s00134-005-2767-1. Epub 2005 Aug 17.

  PMID: 16132888 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ellise Delphin, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 29, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 5, 2015

Record last verified: 2015-04

Locations

US (1)