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Cerebral Oxygenation After Lung Resection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183871
First Posted: August 18, 2010
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
King Faisal University
  Purpose
The investigators hypothesize that the lung resection would be associated with lower jugular bulb oxygen saturation in patients with severe pulmonary dysfunction than in patients with healthy lung functions.

Condition Intervention Phase
Elective Lung Resection Surgery Procedure: Monitoring of cerebral oxygenation Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Changes in Cerebral Oxygenation in Patients With Pulmonary Dysfunction After Lung Resection

Further study details as provided by King Faisal University:

Primary Outcome Measures:
  • jugular bulb oxygenation [ Time Frame: before (baseline) and15 min after induction of anesthesia during two-lung ventilation, 15, 30, 60 min after OLV, and 15 min after resuming of two-lung ventilation (TLV), and 1, 4, 6, 12, 18 and 24 hrs after recovery. ]
    jugular bulb oxygen saturation (SjvO2), estimated cerebral metabolic rate of oxygen [CMRO2], cerebral extraction of oxygen [CEO2], cerebral blood flow equivalent [CBFE], and arterial to jugular difference in oxygen content (AjvDO2)


Secondary Outcome Measures:
  • Respiratory and Hemodynamic Data [ Time Frame: baseline and15 min after induction of anesthesia during two-lung ventilation,1, 4, 6, 12, 18 and 24 hrs after recovery. ]
    arterial oxygen saturation (SaO2,) arterial oxygen and carbon dioxide tensions (PaO2, and PaCO2, respectively), FEV1 FVC, HR, MAP,


Estimated Enrollment: 120
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: good pulmonary functions (group 1)
FVC and/or FEV1 of 80% of predicted or more
Procedure: Monitoring of cerebral oxygenation
The internal jugular vein will be cannulated using ultrasound guidance in a cephalad direction, using the Seldinger J-shaped guidewire and it will be advanced only for 2-3 cm beyond the needle insertion site to avoid vascular injury to the jugular bulb. At which point the catheter is advanced until resistance is met at the jugular bulb, usually about 15 cm. The catheter is then pulled back 0.5-1.0 cm so that the catheter does not continue to abut the roof of the jugular bulb and to minimize the cephalad vascular impact with head movement, thereby reducing the risk of vascular injury. Skull x-ray will be used to confirm placement.
Active Comparator: mild pulmonary dysfunction (group 2)
FVC and/or FEV1 of 70%-79% of predicted
Procedure: Monitoring of cerebral oxygenation
The internal jugular vein will be cannulated using ultrasound guidance in a cephalad direction, using the Seldinger J-shaped guidewire and it will be advanced only for 2-3 cm beyond the needle insertion site to avoid vascular injury to the jugular bulb. At which point the catheter is advanced until resistance is met at the jugular bulb, usually about 15 cm. The catheter is then pulled back 0.5-1.0 cm so that the catheter does not continue to abut the roof of the jugular bulb and to minimize the cephalad vascular impact with head movement, thereby reducing the risk of vascular injury. Skull x-ray will be used to confirm placement.
Active Comparator: moderate pulmonary dysfunction (group 3)
FVC and/or FEV1 of 60%-69% of predicted
Procedure: Monitoring of cerebral oxygenation
The internal jugular vein will be cannulated using ultrasound guidance in a cephalad direction, using the Seldinger J-shaped guidewire and it will be advanced only for 2-3 cm beyond the needle insertion site to avoid vascular injury to the jugular bulb. At which point the catheter is advanced until resistance is met at the jugular bulb, usually about 15 cm. The catheter is then pulled back 0.5-1.0 cm so that the catheter does not continue to abut the roof of the jugular bulb and to minimize the cephalad vascular impact with head movement, thereby reducing the risk of vascular injury. Skull x-ray will be used to confirm placement.
Active Comparator: severe pulmonary dysfunction (group 4)
FVC and/or FEV1 of 50%-59% of predicted
Procedure: Monitoring of cerebral oxygenation
The internal jugular vein will be cannulated using ultrasound guidance in a cephalad direction, using the Seldinger J-shaped guidewire and it will be advanced only for 2-3 cm beyond the needle insertion site to avoid vascular injury to the jugular bulb. At which point the catheter is advanced until resistance is met at the jugular bulb, usually about 15 cm. The catheter is then pulled back 0.5-1.0 cm so that the catheter does not continue to abut the roof of the jugular bulb and to minimize the cephalad vascular impact with head movement, thereby reducing the risk of vascular injury. Skull x-ray will be used to confirm placement.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA II-IV
  • Ages 18-60 yrs.
  • Good or impaired pulmonary function tests

Exclusion Criteria:

  • Decompensated cardiac function (>New York Heart Association II).
  • Hepatic and renal diseases
  • Arrhythmias
  • Moderate pulmonary hypertension (mean pulmonary artery pressure (MPAP) >35 mm Hg),
  • Previous history of pneumonectomy, bilobectomy or lobectomy
  • Cervical spine injury
  • Tracheostomy
  • Coagulopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183871


Locations
Saudi Arabia
King Fahd hospital of the University of Dammam
Al Khubar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
King Faisal University
Investigators
Study Director: Mohamed R El Tahan, M.D. King Faisal University
  More Information

Responsible Party: King Faisal University
ClinicalTrials.gov Identifier: NCT01183871     History of Changes
Other Study ID Numbers: 201011
First Submitted: August 12, 2010
First Posted: August 18, 2010
Last Update Posted: March 26, 2012
Last Verified: March 2012

Keywords provided by King Faisal University:
Cerebral oxygenation
thoracotomy
lung resection
pulmonary dysfunction