Ventilation Strategies for Preventing Lung Collapse During Robotic Surgery

Overseen By Roberto Casal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Severe air-trapping, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to prevent lung collapse during robotic bronchoscopy, a procedure for examining potentially cancerous lung nodules. Researchers compare a side-lying position strategy (Lateral Decubitus Strategy, LADS) with a special breathing technique (Ventilatory Strategy To Prevent Atelectasis, VESPA) to determine which is more effective. Adults undergoing this procedure for nodules up to 3 cm in specific lung areas, who have not experienced severe lung issues, may qualify. As an unphased trial, it allows participants to contribute to innovative research that could enhance future lung procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ventilation strategies are safe for preventing lung collapse during robotic surgery?

Research has shown that the Ventilatory Strategy To Prevent Atelectasis (VESPA) received positive feedback in past studies. It significantly reduced lung collapse (atelectasis) and had lasting effects during procedures like bronchoscopy. Participants generally tolerated the strategy well, with few side effects reported.

The Lateral Decubitus Strategy (LADS) involves positioning patients on their side to prevent lung collapse. Although less direct data exists on its safety, this method is commonly used in other procedures, suggesting it is generally safe. Overall, both strategies appear promising for preventing lung issues during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ventilation strategies because they aim to prevent lung collapse during robotic surgery, which is a big step forward in patient care. The Lateral Decubitus Strategy (LADS) uses a patient's positioning to improve lung ventilation, which could minimize the risk of lung collapse compared to traditional flat positioning methods. On the other hand, the Ventilatory Strategy To Prevent Atelectasis (VESAP) involves specific breathing techniques to keep the lungs open during procedures, offering a new approach to maintaining lung function. Both strategies represent innovative methods that could enhance surgical outcomes and recovery compared to current methods that don't specifically address lung collapse prevention.

What evidence suggests that this trial's ventilation strategies could be effective for preventing lung collapse during robotic surgery?

In this trial, participants will join one of two groups to evaluate strategies for preventing lung collapse during robotic bronchoscopy. Research has shown that the Ventilatory Strategy To Prevent Atelectasis (VESPA), used in Group 1, helps prevent lung collapse during procedures like bronchoscopy. It significantly reduces the risk of lung collapse and is well tolerated by patients. Studies also indicate that its benefits persist after the procedure. Participants in Group 2 will receive the Lateral Decubitus Strategy (LADS), which involves positioning patients on their side during surgery to help keep the lungs open. Although this method is new and innovative, solid evidence is lacking to demonstrate its effectiveness compared to VESPA. Both strategies aim to maintain lung function during robotic bronchoscopy. ^{1 4 5 6 7}

Who Is on the Research Team?

Roberto Casal, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults undergoing diagnostic robotic bronchoscopy for suspicious lung nodules up to 3 cm, located in specific bronchial segments. Participants must have had a recent chest CT and over half the lesion's volume below a certain point on their spine. Excluded are those with history of pneumothorax, pregnancy, ascites, large lung bullae, diaphragmatic paralysis, severe air-trapping or mediastinal adenopathy requiring prior sampling.

Inclusion Criteria

I am an adult scheduled for a lung nodule check under anesthesia.

My lung nodules are no larger than 3 cm and are in specific areas of my lungs.

Voluntary informed consent to participate in the study

Exclusion Criteria

I have been diagnosed with diaphragmatic paralysis.

I have had lung issues or masses larger than 3 cm on my latest CT scan.

I have had a collapsed lung without injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic bronchoscopy using either VESPA or LADS strategy to prevent atelectasis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the bronchoscopy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lateral Decubitus Strategy (LADS)
• Ventilatory Strategy To Prevent Atelectasis

Trial Overview The trial is testing two methods to prevent atelectasis (lung collapse) during robotic bronchoscopy: VESPA (a ventilatory strategy) and LADS (lying on one side). Patients will be randomly assigned to either method to see which is more effective.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.

Group II: Group 1 Experimental Treatment 1 Intervention

Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 21 neonates with tension pulmonary interstitial emphysema (TPIE), lateral decubitus positioning (LDP) was found to be an effective treatment, with a success rate of 90%.

All responding patients either improved or maintained stable respiratory status during treatment, and no complications were reported, suggesting that LDP is a safe and effective initial management strategy for TPIE in neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal tension pulmonary interstitial emphysema in bronchopulmonary dysplasia: treatment with lateral decubitus positioning. Schwartz, AN., Graham, CB.[2022]

Positioning patients in the left lateral decubitus position before laparoscopic surgery enhances the displacement of small-bowel loops, making right colonic mobilization and transection safer and more efficient.

This position not only aids in the surgical procedure but also allows for intraoperative colonoscopy, which can help identify hard-to-find lesions in the colon, as demonstrated in a report involving four patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic right hemicolectomy in left lateral decubitus position. Jager, RM.[2004]

Continuous monitoring of mixed venous saturation (SvO2) during thoracotomy and single-lung ventilation in 23 patients showed that while SvO2 decreased, it was not statistically significant and returned to higher levels after lung re-expansion, indicating stable oxygenation under these conditions.

The study found that SvO2 is a reliable indicator of oxygenation and cardiac output during single-lung ventilation, but changes in SvO2 should be interpreted alongside other hemodynamic and gas measurements to accurately diagnose any issues with oxygen supply and demand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of hemoglobin oxygen saturation in mixed venous blood during thoracic anesthesia with selective single-lung ventilation]. Herrera, A., Pajeulo, A., Morano, MJ., et al.[2013]

Pulmonary atelectasis can occur as a complication during urinary tract surgeries performed in the lateral decubitus position, as highlighted by a case of right upper lobe atelectasis following left radical nephrectomy under general anesthesia.

The atelectasis was effectively treated using saline lavage and bronchoscopic suction, demonstrating a successful intervention for this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right upper lobe atelectasis after upper urinary surgery in the lateral decubitus position--case report. Kabaria, V., Sofair, E., Kubal, K.[2014]

Lateral decubitus positioning, commonly used in orthopedic surgeries, can lead to unique complications related to ophthalmologic, musculoskeletal, neurovascular, and hemodynamic issues.

Orthopedic surgeons need to be aware of these potential complications to effectively prevent and manage them during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Lateral Decubitus Positioning During Orthopaedic Surgery. Zhang, AS., Osorio, C., Stone, BK., et al.[2023]

Endotracheal intubation in the lateral position using a video stylet (VS) is significantly faster than using a fiberoptic (FO) bronchoscope, with average times of 39.5 seconds versus 75.6 seconds, respectively, based on a study of 50 patients.

While the VS method has a high success rate (88% for first attempts), it is associated with a higher incidence of sore throat compared to the FO method, indicating a trade-off between speed and potential discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotracheal intubation in patients undergoing open abdominal surgery in the lateral position: a comparison between the intubating video stylet and fiberoptic intubating bronchoscopy. Wahdan, AS., El-Refai, NAR., Omar, SH., et al.[2021]

In a study of 15 obese patients after upper abdominal surgery, different body positions were tested, revealing that the Trendelenburg position does not significantly affect oxygen saturation levels, allowing for its safe use postoperatively.

While there was a slight improvement in oxygen saturation over the first three days post-surgery, the changes were minimal, indicating that supplemental oxygen can help maintain adequate oxygen levels in obese patients, even when using various positions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of selective drainage positions on oxygen saturation in obese patients after upper abdominal surgery. Bien, MY., Zadai, CC., Kigin, CM., et al.[2015]

In a study of 51 patients undergoing robotic surgery in the Trendelenburg position, pressure-controlled ventilation (PCV) was found to significantly reduce the arterial to end-tidal carbon dioxide gradient (P(a-ET)CO2) compared to volume-controlled ventilation (VCV), indicating better management of CO2 levels during surgery.

PCV also resulted in lower peak airway pressure and improved dynamic compliance without negatively impacting oxygen levels or hemodynamics, suggesting it may be a safer and more effective ventilation strategy for patients in this surgical position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of arterial to end-tidal carbon dioxide gradient P (a-ET)CO2 in volume versus pressure controlled ventilation in patients undergoing robotic abdominal surgery in the Trendelenburg position. A randomised controlled study. Veerasamy, S., Kumar, L., Kartha, A., et al.[2022]

In a study of 28 patients undergoing elective pelvic robotic surgery, using a PEEP strategy tailored to esophageal pressure (VPes-guided) significantly improved oxygenation compared to a gas exchange-guided approach (VGas-guided) at multiple time points during surgery.

The VPes-guided method also resulted in better respiratory mechanics, as indicated by lower respiratory system elastance, suggesting that this approach may enhance patient safety and comfort during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Pressure Versus Gas Exchange to Set PEEP During Intraoperative Ventilation. Cammarota, G., Lauro, G., Sguazzotti, I., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-pulmonary-atelectasis-6-2023-3b267

Ventilation Strategies for Preventing Lung Collapse During ... What data supports the effectiveness of the treatment Lateral Decubitus Strategy (LADS) for preventing lung collapse during robotic surgery? The lateral ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35730780/

Lateral Decubitus Positioning for Mobile CT-guided ... Lateral Decubitus Positioning for Mobile CT-guided Robotic Bronchoscopy: A Novel Technique to Prevent Atelectasis.

3. clinicaltrial.be clinicaltrial.be/en/details/190760?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Randomized Trial Comparing a Ventilatory Strategy To Pr... To compare clinical workflow in robotic bronchoscopy with VESPA and LADS strategies to identify potential improvements in workflow. Trial design.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521689624000284

Robotic bronchoscopy: Evolution of advanced diagnostic ... This review will discuss the evolution of various advancements when tissue biopsy is required: from sputum cytology, nonguided bronchoscopy, percutaneous CT ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/103380/html

Tailored single-lung ventilation approaches and postoperative ... A recent study has demonstrated that the tailored open-lung ventilation strategy, combining RMs with tailored PEEP, provides superior outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10323558/

Preventing atelectasis during bronchoscopy under general ... A novel technique to prevent atelectasis was described by Lin et al., utilizing lateral decubitus positioning for the biopsy of posteriorly ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324781/

Robotic-Assisted Thoracic Surgeries: Anesthetic & Outcomes Overall, the results show that patients undergoing RATS have good tolerance to the anesthetic technique of choice, optimal airway management, ...