Clinical Trials Logo

Clinical Trial Summary

Our objective is to assess whether the use of high flow nasal cannula (Vapotherm, Exeter, NH) with monitored anesthesia care (MAC) during an endobronchial ultrasound (EBUS) bronchoscopy procedure will lead to less procedure interruptions, less hypoxic episodes, shorter duration of hypoxic episodes and shorter procedural durations when compared to regular MAC using a regular nasal canula.

Clinical Trial Description

Background: MAC is a type of conscious sedation delivered by an anesthesiologist, during which different sedative medications are given, usually via the intravenous route, to obtain varying levels of sedation depending on the surgery or procedure. This is routinely done for all EBUS procedures at Cooper University Hospital. Since a MAC anesthesia does not include having a secure airway, occasionally the patient may develop episodes in which their oxygen level drops. During these episodes, the anesthesiologist will stop the procedure temporarily until the oxygen level returns to a normal range. Often, changes in sedation amount is also required during this time. In a traditional MAC, the patient receives oxygen via a nasal cannula or a capnomask. If oxygen is delivered via a capnomask, the routine is to create a hole with scissors in the side of the capnomask in order to allow the bronchoscope into the patient's mouth. The Vapotherm is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. The Vapotherm is a high flow nasal cannula that works by constantly providing humidified and heated high flow oxygen thereby creating positive end expiratory pressure that is useful for alveolar recruitment. It looks similar to nasal cannula but a little thicker and is also placed in the nostrils. EBUS is a technique that uses ultrasound along with bronchoscopy to visualize the airway wall and structures adjacent to it. The clinical application and diagnostic benefits of EBUS have been well established, including diagnosis and staging of lung cancer. EBUS is usually performed under MAC for patient comfort. The route of entry for the EBUS scope requires passage through the vocal cords and into the airways. The procedure tends to cause some discomfort and generally needs anesthesia to make people comfortable. Due to the amount of anesthesia required to subdue the airway reflexes for a smooth procedure, occasionally, the patient may become apneic or obstruct and not take adequate tidal volume breaths, leading to hypoxia. During these instances, the procedure is halted until the patient's oxygen levels return to baseline. We have noticed that anesthesiologists who prefer to use the Vapotherm in place tend to less often interrupt the procedure due to hypoxia. Vapotherm high flow nasal cannula therapy is similar in efficacy to transtracheal catheters, which are intended to attenuate the effects of anatomical dead space on breathing efficiency. The mechanisms include washout of nasopharyngeal dead space, reduction of inspiratory resistance in the nasopharynx, improvement in airway and lung mechanics thereby providing methods to oxygenate without having to interrupt the procedure. All anesthesiologists at Cooper University Hospital are familiar with the Vapotherm high flow nasal cannula. No research has been done in this field specifically regarding to EBUS. There is no anesthetic standard of care that is specific for an EBUS procedure. The anesthesia can be local anesthesia alone, with just topicalization of the airways, or MAC, or even general anesthesia with an endotracheal tube or a laryngeal mask airway. The choice is practitioner dependent. Our experience has been that MAC with Vapotherm high flow leads to less procedural interruptions, less hypoxic episodes and shorter procedural durations. Hypotheses: Our hypothesis is that the use of the Vapotherm high flow nasal cannula with monitored anesthesia care (MAC) is associated with less procedure interruptions, less hypoxic episodes and shorter procedural durations. Significance of the research: If we can prove that the use of a Vapotherm high flow employed during MAC care leads to less procedure interruptions and shorter procedure durations, this would allow us to standardize the type of oxygen supply employed for EBUS in our institution and elsewhere. Less hypoxic episodes would benefit outcomes, lead to less recovery time and earlier discharges. Shorter procedural durations will create greater efficiency in the short procedure unit where the EBUS procedures are performed. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05203328
Study type Interventional
Source The Cooper Health System
Contact Wissam Abouzgheib, MD
Phone (800) 826-6737
Status Not yet recruiting
Phase N/A
Start date February 1, 2022
Completion date January 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00245154 - Paclitaxel + Carboplatin With/Out Cediranib Maleate in Stage III or Stage IV Non-Small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Completed NCT01000025 - PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer Phase 3
Recruiting NCT05087251 - The Transitions Project: Efficacy Trial N/A
Recruiting NCT05248256 - Vertebral Marrow Attention Trial (VMAT) N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT02196844 - Yoga Program for Lung Cancer Patients and Caregivers N/A
Recruiting NCT04957433 - 'Lung Health Check' Biomarker Study
Recruiting NCT04500535 - A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy