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.

  Hide Detailed Description

Detailed Description:

Surgery remains the treatment of choice for patients with resectable lung cancer. However, a significant proportion of patients undergoing lung resections have the associated condition COPD,1 which increases the risk of perioperative complications and death. New techniques in anesthesiology and critical care have enabled patients with COPD to have better outcomes following lung resections. Nowadays, patients with limited lung function, who would have been denied surgery according to the criteria proposed in the past, may undergo pulmonary resection with a low mortality rate.2

Lung resection results in loss of lung parenchyma including residual healthy lung tissue and in reduction in the pulmonary vascular bed. A decrease in residual pulmonary vascular bed after lung resection causes an increase in the right heart afterload, and in others, it would be associated with an increase in the right heart preload.3

The removal of lung parenchyma from patients with carcinoma of the lung, may lead to cardiopulmonary failure or death. A predicted postoperative forced expiratory volume in one second (FEV1) less than 0.8 to 1.0 liter is considered an indicative of a high risk of postoperative chronic ventilatory insufficiency. After pneumonectomy, FEV1 decreases by 29-35% and forced vital capacity (FVC) decreases by 27-44%. After lobectomy, FEV1 and FVC decrease to12-23% and 10-30%, respectively.4

After lobectomy in patients with normal pulmonary functions, there is a transient good maintenance of gas exchange for only 6-12hours, then it is followed with progressive deterioration in oxygen delivery and intra-pulmonary shunt fraction because of peripheral atelectasis 4-13 days after surgery.5 Other investigators reported a significant decrease in maximal oxygen uptake (VO2-Max) and maximal work rate (WR-Max) by 27% and 42%, respectively, 3 months after pneumonectomy, and by13% and 2%, respectively after lobectomy.

In patients with moderate-to-severe pulmonary dysfunction there is significant worsening of pulmonary gas exchange; especially during one-lung ventilation (OLV) which is the mandatory technique to facilitate thoracic surgery. This worsening is more marked in patients undergoing right thoracotomies after lung resection.6

Postoperative lung function changes in the elderly followed the similar trend as in patients with pulmonary dysfunction. The mean postoperative decrease in FEV 1 was 14.16% in the elderly, compared with a 29.23% decrease in patients with normal lung function ( P < 0.05). However, the operative morbidity in the elderly group was significantly lower than in patients with pulmonary dysfunction (23.3% vs. 60%).7

The potential for postoperative neurocognitive dysfunction and its impact on the postoperative course has gained recent attention over the past few years.8 There is an interesting study for the changes in brain tissue oxygenation (rSO2) during OLV for thoracic surgery using near infrared spectroscopy (NIRS), otherwise known as cerebral oximetry, is a non-invasive device that uses infrared light to estimate brain tissue oxygenation which may occur during OLV. The investigators reported significant changes in rSO2 occur during OLV for thoracic surgical procedures without changes in hemodynamic or ventilatory parameters. They recommended future studies to determine the impact of such changes on the postoperative course of these patients.9

According to the above evidences, the changes in oxygen delivery, oxygen uptake and intrapulmonary shunt after lung resection will be reflected on the cerebral blood flow and oxygen delivery and jugular bulb oxygen saturation in patients with impaired pulmonary functions rather than those with healthy lung functions.

Oxygenation of cerebral venous outflow has been investigated as a neuro-monitor for more than 50 years.10-12 Currently, jugular venous oxygen saturation (SjVO2) provides an indirect assessment of cerebral oxygen use and is used to guide physiologic management decisions in a variety of clinical paradigms.13-14 This is simply can be achieved through introducing of an intravascular catheter, similar to those used for central venous pressure monitoring, may be placed retrograde, via the internal jugular vein, into the jugular bulb at the base of skull.15

Jugular venous oxygen is an indirect assessment of cerebral oxygen use. Simplistically, when demand exceeds supply, the brain extracts greater oxygen, resulting in decreased jugular bulb oxygen saturation. If cerebral blood flow (CBF) decreases, a point is eventually reached at which the brain can no longer completely compensate for decreased CBF by a further increase in oxygen extraction. At this point, oxygen consumption decreases and anaerobic metabolism with lactate production ensues. When cerebral oxygen supply exceeds demand, oxygen saturation of jugular bulb blood is increased.15

To our knowledge there is no any study was done on the changes in cerebral oxygenation after lung resections, especially in the high-risk group with pulmonary dysfunction.

Project Objectives:

We hypothesize that the lung resection would be associated with lower jugular bulb oxygen saturation in the patients with severe pulmonary dysfunction than in the patients with healthy lung functions.

  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 September 18, 2014