N/A
N=37
Clamping the Double Lumen Tube
One-lung Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT03508050 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Apr 2020
Primary outcome: Primary: T50-3 — 31.87; 63.81; 33.30; 60.82 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clamping the Double Lumen Tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jean Bussières
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY T50-3 |
31.87; 63.81; 33.30; 60.82 | — |
| SECONDARY Complete Lung Collapse (CLC-clinical) |
28.67; 59.47 | — |
| SECONDARY O2 Concentration of Expired Air at Pleural Opening |
41.87; 11.93 | — |
| SECONDARY Expiratory Volume at Pleural Opening |
178.53; 421.13 | — |
| SECONDARY O2 Concentration of Expired Air at the Beginning of One-lung Ventilation |
40.93; 35.13 | — |
| SECONDARY Optimization of Lung Collapse |
0; 1 | — |
| SECONDARY Quality of Oxygenation During One-lung Ventilation (PaO2 ) |
162.86; 128.60 | — |
| SECONDARY Quality of Oxygenation During One-lung Ventilation (SaO2) |
97.78; 95.67 | — |
| SECONDARY Surgery Duration |
89.27; 88.40 | — |
| SECONDARY Postoperative Atelectasis |
1; 6 | — |
| SECONDARY Quality of Lung Collapse (Clinical) at 0 Minute |
0; 1; 14; 14; 1; 0 | — |
| SECONDARY Quality of Lung Collapse (Clinical) at 10 Minutes |
1; 0; 14; 14; 0; 1 | — |
| SECONDARY Quality of Lung Collapse (Clinical) at 20 Minutes |
0; 0; 8; 14; 7; 1 | — |
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).
Eligibility Criteria
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
- Known or anticipated difficult tracheal intubation.
- Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
- Severe COPD or asthma (FEV1 <50%).
- Prior intrathoracic surgery (including cardiac surgeries).
- Pleural or interstitial pathology.
- Previous chemotherapy or thoracic radiotherapy.
- Acute or chronic pulmonary infection.
- Endobronchial mass.
- Tracheostomy.
B- Post-randomisation
- Bronchoscopic findings contraindicating the insertion of DLT.
- VATS findings that cancel the surgery.
- Severe desaturation (SatO2 < 90%) during the observation period.
- Any need to reinflate the collapse lung.
Data sourced from ClinicalTrials.gov (NCT03508050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.