Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

NCT00538161 | Completed DMC

• 1 other identifier: 2007P000113
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute lung injury; cardiac surgery; The incidence of ARDS after elective cardiac surgery is 1-3%; The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery.; The purpose of this study is to assess the efficacy of low tidal volume ventilation.; Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.

Outcome Measures

Primary Outcomes (1)

• Time to extubation

  the time patient was extubated in the ICU

Secondary Outcomes (1)

• Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.

  measurement of blood gas at 4, 8 , 12 and 24 hours post surgery

Study Arms (2)

Low tidal volume arm

EXPERIMENTAL

Other: Ventilation strategy

Conventional tidal volume arm

ACTIVE COMPARATOR

Other: Ventilation strategy

Interventions

Ventilation strategy OTHER

Conventional tidal volume arm; Low tidal volume arm

Eligibility Criteria

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

You may qualify if:

• Patients coming in for cardiac surgical procedures will be recruited into the study.
• Both men and women will be recruited into the study.
• All patients over the age of 18 will be recruited into the study.
• Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.

You may not qualify if:

• Patients with preexisting respiratory failure and active infection will be excluded from the study.
• Patients undergoing one lung ventilation during surgery will be excluded from the study.
• Patients undergoing emergency cardiac surgery will be excluded from the study.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Daniel Talmor, MD

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 30, 2007
• First Posted: October 2, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2011
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

US (1)