Thoracic, Diseases Clinical Trial
Official title:
The Influence Of Continuous Positive Airway Pressure and Positive End-Expiratory Pressure, With A Recruitment Maneuver, On Oxygenation During One Lung Ventilation Employing A Lung Protective Ventilation Strategy.
Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated
(breathing performed by a breathing machine) during anesthesia using a lung protective
ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the
anesthesiologist is able to ventilate only one lung by inserting a special breathing tube,
allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial
two interventions used to improve blood oxygen levels during one lung ventilation will be
compared . The two interventions are:
1. Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing)
lung and
2. Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the
ventilated (breathing) lung.
CPAP is performed by applying a steady flow of oxygen to the non ventilated (non breathing)
lung at a continuous gentle pressure of 5cmH20.
To perform a Recruitment Maneuver (RM) the anesthesiologist inflates the ventilated
(breathing) lung with oxygen, holding the breath for 25 seconds so all the lung is opened up.
Immediately after the recruitment maneuver PEEP will be applied. PEEP is an action which also
helps keep the lung open, maintaining the benefits achieved by the RM. It is performed by
adjusting settings on the ventilator (breathing machine). The ventilator creates and applies
a gentle pressure (5cmH20) to the ventilating lung at the end of each breath.
The outcome measure will be the oxygen content in blood (PaO2), measured in mmHg, using blood
sample analysis.
The null hypothesis is that compared to CPAP, RM-PEEP does not significantly increase the
oxygen content of blood during OLV when using a lung protective ventilation strategy.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age 18 or older 2. Competent to give consent to enroll in study 3. Booked for scheduled open thoracotomy which involves wedge resection, lobectomy or pneumonectomy requiring OLV 4. American Society of Anesthesia physical status score (ASA) 1-4 Exclusion Criteria: 1. Unable to give consent 2. Pregnant women 3. Inability to insert an arterial line 4. Presence of other significant pulmonary impairment (PaO2 on room air <50mmHg, PaCO2 >50mmHg or known pulmonary hypertension (mean PAP>25mmHg) 5. Presence of significant cardiovascular disease 6. Altered liver function (Child Pugh scale =B) 7. Patients with bullous lung disease. - |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Victoria Hospital | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
Badner NH, Goure C, Bennett KE, Nicolaou G. Role of continuous positive airway pressure to the non-ventilated lung during one-lung ventilation with low tidal volumes. HSR Proc Intensive Care Cardiovasc Anesth. 2011;3(3):189-94. — View Citation
Cohen E, Eisenkraft JB, Thys DM, Kirschner PA, Kaplan JA. Oxygenation and hemodynamic changes during one-lung ventilation: effects of CPAP10, PEEP10, and CPAP10/PEEP10. J Cardiothorac Anesth. 1988 Feb;2(1):34-40. — View Citation
Fan E, Wilcox ME, Brower RG, Stewart TE, Mehta S, Lapinsky SE, Meade MO, Ferguson ND. Recruitment maneuvers for acute lung injury: a systematic review. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1156-63. doi: 10.1164/rccm.200802-335OC. Epub 2008 Sep 5. Review. — View Citation
Fernández-Pérez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. — View Citation
Hoftman N, Canales C, Leduc M, Mahajan A. Positive end expiratory pressure during one-lung ventilation: selecting ideal patients and ventilator settings with the aim of improving arterial oxygenation. Ann Card Anaesth. 2011 Sep-Dec;14(3):183-7. doi: 10.4103/0971-9784.83991. — View Citation
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. Review. — View Citation
Licker M, de Perrot M, Spiliopoulos A, Robert J, Diaper J, Chevalley C, Tschopp JM. Risk factors for acute lung injury after thoracic surgery for lung cancer. Anesth Analg. 2003 Dec;97(6):1558-65. — View Citation
Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24. — View Citation
Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9. — View Citation
Schilling T, Kozian A, Huth C, Bühling F, Kretzschmar M, Welte T, Hachenberg T. The pulmonary immune effects of mechanical ventilation in patients undergoing thoracic surgery. Anesth Analg. 2005 Oct;101(4):957-65, table of contents. — View Citation
Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. Review. — View Citation
Tusman G, Böhm SH, Sipmann FS, Maisch S. Lung recruitment improves the efficiency of ventilation and gas exchange during one-lung ventilation anesthesia. Anesth Analg. 2004 Jun;98(6):1604-9, table of contents. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Partial pressure of oxygen in blood | Time 0 (the patient is anesthetized and being ventilated on two lungs, just prior to the commencement of one lung ventilation). Time 20 minutes (patient has been ventilated on one lung for 20 minutes and immediately prior to instituting one of the two intervention arms). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or RM-PEEP]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or RM-PEEP]) | Day 1 | |
| Secondary | Hypoxia | The incidence of hypoxia (oxygen saturation falling below 90%, measured by pulse oximetry) throughout the entire study period will be recorded and correlated with the study stage. | Day 1 | |
| Secondary | Hypoxia intervention techniques | The incidence of necessary hypoxia (oxygen saturation below 90%) intervention techniques (performed by the attending anesthesiologist) will be recorded once the patient has been commenced on one lung ventilation. The interventions recorded will be The need to revert back to two lung ventilation The need to clamp the operative pulmonary artery The need to add CPAP to the non ventilated lung despite being in the RM-PEEP arm of the study. The need to add a RM-PEEP to the ventilated lung despite being in the CPAP arm of the study |
Day 1 |