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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01003730
• Other study ID #: 0120080132
• Status: Terminated
• Phase: N/A
• First received: October 21, 2009
• Last updated: May 1, 2015
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The ability to provide mechanical ventilation that will not injure and may protect normal lungs during major surgical procedures of long duration may improve postoperative outcomes and decrease morbidity and mortality. The aim of the current study was to identify ventilator strategies that are less damaging to normal lungs. The investigators plan to compare three ventilation strategies commonly utilized in the operating room in normal lungs. One group will be ventilated with high tidal volume (15 mL/kg PBW) and low PEEP (3 cm H2O), another group ventilated with low tidal volume (6 mL/kg PBW) and low PEEP (3 cm H2O) and the final group ventilated with low tidal volume (6 mL/kg PBW) and high PEEP (10 cm H2O). This study will show the effects of these commonly used methods of ventilation on pulmonary mechanics, systemic and pulmonary inflammatory markers and outcomes in patients with normal lungs undergoing surgery of long duration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
United States	UMDNJ/University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Drömann 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. Epub 2005 Aug 17. — View Citation

Wrigge H, Zinserling J, Stüber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine levels in serum and bronchial aspirate		during the operative procedure	No
Secondary	arterial blood gases		during the operative procedure	Yes
Secondary	subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission		wothin 30 days of surgery	No