Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide

Withdrawn before enrolling · Not applicable

Conditions studied: Low Tidal Volume Ventilation, Acute Respiratory Distress Syndrome

In brief

The purpose of this protocol is to perform serial physiological measurements and blood testing on mechanically ventilated patients comparing conditions of eucapnia and hypercapnia in the same patient. We will be testing two hypotheses: (1) while administering inspired carbon dioxide (CO2), eucapnia achieved by high respiratory rate (EHR) significantly decreases pulmonary artery pressures compared to hypercapnia with a lower respiratory rate (HLR), and (2) that EHR decreases myocardial strain compared to HLR.

Key facts

Study ID

NCT01927237

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2013-09-01

Expected to finish

2014-08-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Able to consent pre-operatively prior to scheduled cardiac surgery.
• Intubation on mechanical ventilation post-operatively.
• Presence of a pulmonary artery catheter and/or central venous catheter as part of usual care post-operatively.
• Presence of a radial, brachial, or femoral arterial catheter as part of usual care post-operatively.

You may not qualify if…

• Significant intra-operative or immediate post-operative complications, such as uncontrolled bleeding or persistent hemodynamic instability.
• Intra-cardiac or intrapulmonary shunt.
• Persistent post-operative moderate or severe hypoxemia, defined as PaO2/FiO2 < 200 mmHg.
• Moderate or severe lung disease, including moderate or severe chronic obstructive pulmonary disease (COPD) or asthma.
• Recently treated for bleeding varices, stricture, or hematemesis, esophageal trauma, recent esophageal surgery, or other contraindication to transesophageal echocardiography.
• Severe coagulopathy (platelet count < 10,000 or international normalized ratio [INR] > 4).
• History of lung, heart, or liver transplant.
• Elevated intracranial pressure or conditions where hypercapnia-induced elevations in intracranial pressure should be avoided, including:
• Intracranial hemorrhage
• Cerebral contusion
• Cerebral edema
• Mass effect (midline shift on head CT)
• Flat EEG for > 2 hours
• Evidence of active air leak from the lung, such as broncho-pleural fistula or ongoing air leak from an existing chest tube.
• Treating physician refusal.
• Inability to obtain informed consent directly from the subject prior to surgery.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.