Comparison of Oxygen Saturation During Different Intraoperative Positions

NCT01744886 | Terminated

• 1 other identifier: B126201215656
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues. Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a combination of these) require the use of OLV as well. Its effect on oxygen saturation has not been studied previously. The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus thoracotomies.

Conditions

One-Lung Ventilation

Keywords

One-Lung Ventilation; Thoracic Surgical Procedures; Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• oxygen saturation

  To compare oxygen saturation during one-lung ventilation in patients undergoing lateral decubitus for non-cardiac thoracic surgery, requiring more than 20 minutes of one-lung ventilation using double lumen intubation, versus patients undergoing port-access cardiac surgical procedures.

  20 minutes after initiation of one-lung ventilation

Secondary Outcomes (1)

• oxygen saturation

  15 minutes of one-lung ventilation after patient positioning

Other Outcomes (1)

• oxygen saturation

  each 15 min once one-lung ventilation is initiated

Study Arms (2)

lung surgery

ACTIVE COMPARATOR

An initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air. A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. If necessary, measures are taken to maintain oxygenation during one lung ventilation.

Procedure: maintain oxygenation during one lung ventilation

port-access cardiac surgery

ACTIVE COMPARATOR

An initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air. A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. In the port-access group, FIO2 is maintained on 1 after the stopping of the ECC, so PaO2 will become our only indicator for oxygenation. If necessary, measures are taken to maintain oxygenation during one lung ventilation.

Procedure: maintain oxygenation during one lung ventilation

Interventions

maintain oxygenation during one lung ventilation PROCEDURE

All study patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O PEEP. Respiratory frequency and tidal volume will be adjusted to maintain ETCO2 between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously. If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient 5 cm H2O of CPAP is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung.

lung surgery; port-access cardiac surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lateral decubitus lung surgery or port-access.
• American Society of Anesthesiologists Physical Status (ASA) II or III.
• Age between 18-80 years.
• Patients willing to sign consent.

You may not qualify if:

• Pre-existing interstitial lung disease.
• Pre-existing obstructive airway disease.
• Inability or unwillingness of study participant to give written informed consent.
• Patients expected to have a difficult intubation for anatomical reasons.

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (2)

• Watanabe S, Noguchi E, Yamada S, Hamada N, Kano T. Sequential changes of arterial oxygen tension in the supine position during one-lung ventilation. Anesth Analg. 2000 Jan;90(1):28-34. doi: 10.1097/00000539-200001000-00007.

  PMID: 10624971 BACKGROUND

• Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.

  PMID: 19417615 BACKGROUND

Study Officials

• José Coddens, MD

  OLV Hospital Aalst, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Staff Anesthetist

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 7, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

BE (1)