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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sugantha Sundar, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00538161
First received: September 30, 2007
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Acute Respiratory Distress Syndrome
Other: Ventilation strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Time to extubation [ Time Frame: the time patient was extubated in the ICU ]

Secondary Outcome Measures:
  • Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery. [ Time Frame: measurement of blood gas at 4, 8 , 12 and 24 hours post surgery ]

Enrollment: 150
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low tidal volume arm Other: Ventilation strategy
Active Comparator: Conventional tidal volume arm Other: Ventilation strategy

Detailed Description:
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00538161

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Director: Daniel Talmor, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Sugantha Sundar, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00538161     History of Changes
Other Study ID Numbers: 2007P000113
Study First Received: September 30, 2007
Last Updated: March 15, 2017

Keywords provided by Beth Israel Deaconess Medical Center:
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.

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on March 27, 2017