Isocapnic Hyperventilation - an Alternative Method
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|ClinicalTrials.gov Identifier: NCT03074110|
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Neoplasms||Device: Isocapnic hyperventilation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Isocapnic Hyperventilation for Enhancing Recovery After Inhalation Anaesthesia - an Alternative Method|
|Actual Study Start Date :||November 11, 2016|
|Actual Primary Completion Date :||August 15, 2017|
|Actual Study Completion Date :||August 15, 2017|
Active Comparator: Isocapnic hyperventilation
After end of surgery, hyperventilation and administration of a small, precalculated amount of CO2 into the breathing circuit will be performed.
Device: Isocapnic hyperventilation
Mechanical hyperventilation to enhance elimination of inahalation anesthetics. Administration of a precalculated flow of CO2 according to gender and weight into the inspiratory limb of the breathing circuit in order to avoid hypocapnia.
Other Name: Normocapnic hyperventilation
No Intervention: Standard procedure
After end of surgery, patients will be subdued to a standard weaning procedure.
- Time to extubation [ Time Frame: 5-20 minutes ]
- Time to eye-opening [ Time Frame: 10-25 minutes ]
- Time to discharge from OR [ Time Frame: 15-40 minutes ]
- Postoperative recovery [ Time Frame: 60 minutes ]Postoperative quality of recovery (PQRS) scale
- Time to eligible for discharge from post-anaesthesia care unit (PACU) [ Time Frame: 1-6 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074110
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|