Cerebral Oxygenation After Lung Resection

NCT01183871 | Completed Phase 1 DMC

• 1 other identifier: 201011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elective; Lung Resection; Surgery

Keywords

Cerebral oxygenation; thoracotomy; lung resection; pulmonary dysfunction

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  baseline and15 min after induction of anesthesia during two-lung ventilation,1, 4, 6, 12, 18 and 24 hrs after recovery.

Study Arms (4)

good pulmonary functions (group 1)

ACTIVE COMPARATOR

FVC and/or FEV1 of 80% of predicted or more

Procedure: Monitoring of cerebral oxygenation

mild pulmonary dysfunction (group 2)

ACTIVE COMPARATOR

FVC and/or FEV1 of 70%-79% of predicted

Procedure: Monitoring of cerebral oxygenation

moderate pulmonary dysfunction (group 3)

ACTIVE COMPARATOR

FVC and/or FEV1 of 60%-69% of predicted

Procedure: Monitoring of cerebral oxygenation

severe pulmonary dysfunction (group 4)

ACTIVE COMPARATOR

FVC and/or FEV1 of 50%-59% of predicted

Procedure: Monitoring of cerebral oxygenation

Interventions

Monitoring of cerebral oxygenation PROCEDURE

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.

good pulmonary functions (group 1); mild pulmonary dysfunction (group 2); moderate pulmonary dysfunction (group 3); severe pulmonary dysfunction (group 4)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal University: lead

Study Sites (1)

King Fahd hospital of the University of Dammam

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Study Officials

• Mohamed R El Tahan, M.D.

  King Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 18, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

SA (1)