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Completed

NCT Number: NCT03074110

Isocapnic Hyperventilation - 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients scheduled for major elective ear-nose-throat (ENT) surgery after informed consent was obtained during the pre-operative evaluation.

Exclusion criteria

  • Patients with severe pulmonary or circulatory disease

Treatment and study plan

Isocapnic hyperventilation

Device

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 names: Normocapnic hyperventilation

Primary outcomes

  1. Time to extubation

    Time frame: 5-20 minutes

  2. Time to eye-opening

    Time frame: 10-25 minutes

  3. Time to discharge from OR

    Time frame: 15-40 minutes

Secondary outcomes

  1. Postoperative recovery

    Time frame: 60 minutes

    Postoperative quality of recovery (PQRS) scale

  2. Time to eligible for discharge from post-anaesthesia care unit (PACU)

    Time frame: 1-6 hours

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Isocapnic Hyperventilation for Enhancing Recovery After Inhalation Anaesthesia - an Alternative Method

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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