Clamping the Double Lumen Tube

One-lung Ventilation Clinical Trial

— C-TDL  

Official title:

Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508050
• Other study ID #: 21436
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: April 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it.

The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air.

The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.

This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).

Description:

One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated.

Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening.

A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas.

Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group.

Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded.

The hypothesis is that by withholding gas exchange between the NVL and ambient air from the beginning of OLV to the pleural opening, the resorption atelectasis will be facilitated. Consequently, lung collapse of the NVL will occur faster when clamping its specific lumen on the DLT instead of letting it communicate with ambient air like anesthesiologists usually do.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV.

• More than 18 years old.

• Having read, understand and signed the consent form presented at the pre-operative evaluation

Exclusion criteria :

A- Pre-operative

1. Known or anticipated difficult tracheal intubation.

2. Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.

3. Severe COPD or asthma (FEV1 <50%).

4. Prior intrathoracic surgery (including cardiac surgeries).

5. Pleural or interstitial pathology.

6. Previous chemotherapy or thoracic radiotherapy.

7. Acute or chronic pulmonary infection.

8. Endobronchial mass.

9. Tracheostomy.

B- Post-randomisation

1. Bronchoscopic findings contraindicating the insertion of DLT.

2. VATS findings that cancel the surgery.

3. Severe desaturation (SatO2 < 90%) during the observation period.

4. Any need to reinflate the collapse lung.

Related Conditions & MeSH terms

• One-lung Ventilation

Intervention

Device:
• Clamping the Double Lumen Tube
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jean Bussières

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Bardoczky GI, Engelman E, d'Hollander A. Continuous spirometry: an aid to monitoring ventilation during operation. Br J Anaesth. 1993 Nov;71(5):747-51. — View Citation

Bussières JS, Slinger P. Correct positioning of double-lumen tubes. Can J Anaesth. 2012 May;59(5):431-6. doi: 10.1007/s12630-012-9689-5. Epub 2012 Mar 7. English, French. — View Citation

Bussières JS, Somma J, Del Castillo JL, Lemieux J, Conti M, Ugalde PA, Gagné N, Lacasse Y. Bronchial blocker versus left double-lumen endotracheal tube in video-assisted thoracoscopic surgery: a randomized-controlled trial examining time and quality of lung deflation. Can J Anaesth. 2016 Jul;63(7):818-27. doi: 10.1007/s12630-016-0657-3. Epub 2016 May 2. — View Citation

Campos JH, Reasoner DK, Moyers JR. Comparison of a modified double-lumen endotracheal tube with a single-lumen tube with enclosed bronchial blocker. Anesth Analg. 1996 Dec;83(6):1268-72. — View Citation

Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2. Review. — View Citation

Joyce CJ, Baker AB, Kennedy RR. Gas uptake from an unventilated area of lung: computer model of absorption atelectasis. J Appl Physiol (1985). 1993 Mar;74(3):1107-16. — View Citation

Pfitzner J, Peacock MJ, McAleer PT. Gas movement in the nonventilated lung at the onset of single-lung ventilation for video-assisted thoracoscopy. Anaesthesia. 1999 May;54(5):437-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T50-3	Moment where the probability of having a complete lung collapse is 50%	From the beginning of surgery (pleural opening) until 120 minutes
Secondary	Complete Lung Collapse (CLC-clinical)	The time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery	From the beginning of surgery (pleural opening) until 60 minutes
Secondary	O2 Concentration of Expired Air at Pleural Opening	A measure of the O2 concentration of the expiratory air at pleural opening	From pleural opening and lasting 60 seconds
Secondary	Expiratory Volume at Pleural Opening	A measure of the expiratory volume (EV) at pleural opening	From pleural opening and lasting 60 seconds
Secondary	O2 Concentration of Expired Air at the Beginning of One-lung Ventilation	A measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)	From the beginning of one-lung ventilation and lasting 60 seconds
Secondary	Optimization of Lung Collapse	Number of Participants needing Other Interventions to Optimize Lung Collapse	From the beginning of surgery (pleural opening) until 60 minutes
Secondary	Quality of Oxygenation During One-lung Ventilation (PaO2 )	An evaluation of the PaO2 during one-lung ventilation	25 minutes after pleural opening
Secondary	Quality of Oxygenation During One-lung Ventilation (SaO2)	An evaluation of the SaO2during one-lung ventilation	25 minutes after pleural opening
Secondary	Surgery Duration	Time required for completion of the surgery	From the beginning of surgery (pleural opening) until 120 minutes
Secondary	Postoperative Atelectasis	Number of atelectasis detected by Postoperative X-Ray	End of hospitalization
Secondary	Quality of Lung Collapse (Clinical) at 0 Minute	A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome	At pleural opening (0 minute)
Secondary	Quality of Lung Collapse (Clinical) at 10 Minutes	A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome	10 minutes after pleural opening
Secondary	Quality of Lung Collapse (Clinical) at 20 Minutes	A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome	20 minutes after pleural opening