Oropharyngeal Neoplasms Clinical Trial
Official title:
Isocapnic Hyperventilation for Enhancing Recovery After Inhalation Anaesthesia - an Alternative Method
Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery, the investigators evaluated the feasibility of an alternative technique of IHV. By performing a prospective, randomised controlled study, the investigators want to further test this alternative method for IHV.
Isocapnic hyperventilation (IHV) provides an alternative method for weaning from inhalation
anaesthesia which decreases the time to eye-opening, extubation and time spent in the PACU.
The method is well known since at least 40-50 years and involves the maintenance of a stable
CO2 level during hyperventilation, which increases the elimination of anaesthetic gas without
producing hypocapnia. Studies have declared that the reduction in time to eye-opening is
50-60 % compared to a standard weaning procedure after inhalation anaesthesia.
There are several principally different ways to maintain the CO2 level during
hyperventilation, where a number of technical solutions that add dead-space to the
anaesthesia circuit and thereby produce rebreathing of CO2 during hyperventilation are the
most studied methods so far. However, the original method of directly adding CO2 to the
breathing circuit during hyperventilation could be considered in need of a re-evaluation, as
modern anaesthesia delivery units and monitoring equipment to a great extent can eliminate
the risk of hypercapnia, that was described with this procedure in the 1980ies.
An alternative IHV method is to directly infuse CO2 to the inspiratory limb of the breathing
circuit through a mixing box while using mechanical hyperventilation by a standardised
protocol. This technique was recently evaluated by the investigators, in a bench test, and in
an in vivo model. Based on these studies, the CO2 dosage needed to achieve isocapnia during
HV at various levels of alveolar ventilation, CO2 production and dead space was estimated and
a gender- and weight-based nomogram for CO2 delivery during IHV was constructed. Furthermore,
the investigators could show, in vivo, that the washout time of sevoflurane anaesthesia was
one-third compared to normal ventilation. The feasibility of this IHV method was evaluated in
a pilot study in humans, based on the results of our two previous experimental studies. To
finalize the project the investigators now conduct a prospective randomized trial to evaluate
the efficacy of the method, compared to a standard weaning procedure, after long-term
sevoflurane anaesthesia.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03239834 -
Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
|
||
Recruiting |
NCT00251381 -
Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
|
Phase 2 | |
Enrolling by invitation |
NCT04266093 -
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
|
||
Recruiting |
NCT02792322 -
Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck
|
N/A | |
Active, not recruiting |
NCT00918710 -
Human Papillomavirus and Oropharynx Carcinoma
|
N/A | |
Recruiting |
NCT05412628 -
Investigating the Association Between Microbiota and Esophageal/Oropharyngeal Cancer
|
N/A | |
Recruiting |
NCT04124198 -
Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
|
N/A | |
Completed |
NCT00721799 -
F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
|
Phase 2 | |
Recruiting |
NCT00181038 -
Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery
|
Phase 3 | |
Terminated |
NCT04015336 -
E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer
|
Phase 2 | |
Withdrawn |
NCT04044950 -
A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer
|
Phase 2 | |
Completed |
NCT02262247 -
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures
|
N/A | |
Terminated |
NCT01687413 -
Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
|
Phase 3 | |
Completed |
NCT01530997 -
De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
|
Phase 2 | |
Completed |
NCT03010813 -
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery
|
N/A | |
Completed |
NCT03077243 -
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
|
Phase 2 | |
Terminated |
NCT02045186 -
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
N/A | |
Withdrawn |
NCT02298595 -
Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02281955 -
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
|
Phase 2 | |
Terminated |
NCT01525927 -
Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
|
Phase 2 |