Comparison of Oxygen Saturation During Different Intraoperative Positions

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Onze Lieve Vrouw Hospital
Sponsor:
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT01744886
First received: December 6, 2012
Last updated: July 28, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
One-Lung Ventilation
Procedure: maintain oxygenation during one lung ventilation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • oxygen saturation [ Time Frame: 20 minutes after initiation of one-lung ventilation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • oxygen saturation [ Time Frame: 15 minutes of one-lung ventilation after patient positioning ] [ Designated as safety issue: Yes ]
    To assess if oxygen saturation during one-lung ventilation depends on patient positioning.


Other Outcome Measures:
  • oxygen saturation [ Time Frame: each 15 min once one-lung ventilation is initiated ] [ Designated as safety issue: Yes ]
    To assess if more interventions are needed to maintain oxygenation during one-lung ventilation in port-access procedures compared with the non-cardiac surgical procedures under one lung ventilation in lateral decubitus


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lung surgery

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

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.

Active Comparator: port-access cardiac surgery

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

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.


Detailed Description:

OLV is a technique that allows isolation of the individual lung under anesthesia. It is required for a number of thoracic surgical procedures as well as port-access procedures.

The use of a double lumen tube allows easy switching from two-lung to single lung ventilation.

For many thoracic operations the patient will be in the lateral decubitus position. The primary physiologic change that takes place on initiation of OLV is the presence of trans-pulmonary shunting, causing impaired oxygenation and occasionally hypoxemia. The degree of shunt is reduced due to the effect of gravity which increases pulmonary blood flow to the dependent lung and it will be further decreased due to a phenomenon termed hypoxic pulmonary vasoconstriction (HPV).

Hypoxemia may occur during OLV in lateral decubitus position due to the restriction of the dependent lung expansion caused by mediastinal weight therefore leading to atelectasis. Increased ventilation pressure and lung volume of the dependent lung impedes perfusion and contributes to hypoxemia.

Presentation of hypoxemia during OLV is multifactorial. It depends on the operation side (OLV better in left thoracotomies), on preoperative lung function [best indicator = Partial Pressure of Oxygen in Arterial Blood (PaO2) divided by Fraction of Inspired Oxygen (FIO2)] and on the distribution of perfusion. The PaO2/FIO2 is the best parameter to describe the full spectrum of ventilation-perfusion abnormalities, independent of the inspired oxygen concentration level.

The patients are divided into 2 groups according to the surgical procedure as follows:

Port-access group (n=25), and lateral decubitus lung surgery group (n=25). Standard monitoring will be applied intraoperatively [electrocardiography (ECG), pulse-oxymetry (SpO2), invasive and non-invasive blood pressure]. After induction of anesthesia, an appropriately sized double lumen tube will be inserted and its position will be checked using fibroscopy. All 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 of positive end-expiratory pressure (PEEP). Respiratory frequency and tidal volume will be adjusted to maintain end-tidal carbon dioxide (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, continuous positive airway pressure (CPAP) [5 cm water (H2O) pressure] 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT01744886

Contacts
Contact: Guy Cammu, MD, PhD +32 53 724111 guy.cammu@olvz-aalst.be
Contact: José Coddens, MD +32 53 724111 jose.coddens@olvz-aalst.be

Locations
Belgium
OLV Hospital Recruiting
Aalst, Belgium, 9300
Contact: José Coddens, MD    +32 53 724111    jose.coddens@olvz-aalst.be   
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
Study Chair: José Coddens, MD OLV Hospital Aalst, Belgium
  More Information

Publications:
Responsible Party: Guy CAMMU, MD, PhD, Staff Anesthetist, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT01744886     History of Changes
Other Study ID Numbers: B126201215656
Study First Received: December 6, 2012
Last Updated: July 28, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Onze Lieve Vrouw Hospital:
One-Lung Ventilation
Thoracic Surgical Procedures
Cardiac Surgical Procedures

Additional relevant MeSH terms:
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014