ElectivePhase 1NCT01183871
Cerebral Oxygenation After Lung Resection
A Phase 1 study testing Monitoring of cerebral oxygenation in people with Elective and Lung Resection, run by King Faisal University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Elective, Lung Resection, Surgery
- What is being tested?
- Monitoring of cerebral oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA II-IV
- Ages 18-60 yrs.
- Good or impaired pulmonary function tests
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Fahd hospital of the University of Dammam
Khobar, Eastern Province, 31952
About this study
Official title: Changes in Cerebral Oxygenation in Patients With Pulmonary Dysfunction After Lung Resection
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.
Read the 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.
- Conditions
- Elective, Lung Resection, Surgery
- Being tested
- Monitoring of cerebral oxygenation
- Keywords
- Cerebral oxygenation, thoracotomy, lung resection, pulmonary dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of cerebral oxygenationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| good pulmonary functions (group 1) | Active comparator | FVC and/or FEV1 of 80% of predicted or more Receives: Procedure: Monitoring of cerebral oxygenation |
| mild pulmonary dysfunction (group 2) | Active comparator | FVC and/or FEV1 of 70%-79% of predicted Receives: Procedure: Monitoring of cerebral oxygenation |
| moderate pulmonary dysfunction (group 3) | Active comparator | FVC and/or FEV1 of 60%-69% of predicted Receives: Procedure: Monitoring of cerebral oxygenation |
| severe pulmonary dysfunction (group 4) | Active comparator | FVC and/or FEV1 of 50%-59% of predicted Receives: Procedure: Monitoring of cerebral oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
jugular bulb oxygenation
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)
Measured: 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.
Secondary outcomes (1)
Respiratory and Hemodynamic Data
arterial oxygen saturation (SaO2,) arterial oxygen and carbon dioxide tensions (PaO2, and PaCO2, respectively), FEV1 FVC, HR, MAP,
Measured: baseline and15 min after induction of anesthesia during two-lung ventilation,1, 4, 6, 12, 18 and 24 hrs after recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R El Tahan, M.D., Study director, King Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183871
- Sponsor's protocol ID
- 201011
- Status last verified
- Mar 2012
- First submitted
- 12 Aug 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation in Patients With Pulmonary Dysfunction After Lung Resection
- ClinicalTrials.gov ID
- NCT01183871
- Acronym / sponsor ID
- 201011
- Conditions
- Elective, Lung Resection, Surgery
- Keywords
- Cerebral oxygenation, thoracotomy, lung resection, pulmonary dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| good pulmonary functions (group 1) | Active comparator | Procedure: Monitoring of cerebral oxygenationFVC and/or FEV1 of 80% of predicted or more |
| mild pulmonary dysfunction (group 2) | Active comparator | Procedure: Monitoring of cerebral oxygenationFVC and/or FEV1 of 70%-79% of predicted |
| moderate pulmonary dysfunction (group 3) | Active comparator | Procedure: Monitoring of cerebral oxygenationFVC and/or FEV1 of 60%-69% of predicted |
| severe pulmonary dysfunction (group 4) | Active comparator | Procedure: Monitoring of cerebral oxygenationFVC and/or FEV1 of 50%-59% of predicted |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA II-IV
- Ages 18-60 yrs.
- Good or impaired pulmonary function tests
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of cerebral oxygenationThe 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. | Procedure or surgery | good pulmonary functions (group 1), mild pulmonary dysfunction (group 2), moderate pulmonary dysfunction (group 3), severe pulmonary dysfunction (group 4) |
Primary outcome
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)
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed R El Tahan, M.D. study director
King Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monitoring of cerebral oxygenation in people with Elective and Lung Resection, run by King Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.