Cerebral Oxygenation After Lung Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
King Faisal University
ClinicalTrials.gov Identifier:
NCT01183871
First received: August 12, 2010
Last updated: March 22, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: King Faisal University
ClinicalTrials.gov Identifier: NCT01183871     History of Changes
Other Study ID Numbers: 201011
Study First Received: August 12, 2010
Last Updated: March 22, 2012
Health Authority: Saudi Arabia:University of Dammam

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

ClinicalTrials.gov processed this record on October 23, 2014