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Isocapnic Hyperventilation - an Alternative Method

Primary Purpose

Oropharyngeal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Isocapnic hyperventilation
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oropharyngeal Neoplasms focused on measuring Inhalation Anaesthetics, Sevoflurane, Carbon Dioxide, Hyperventilation, Anaesthesia Recovery Period, Ventilators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Isocapnic hyperventilation

Standard procedure

Arm Description

After end of surgery, hyperventilation and administration of a small, precalculated amount of CO2 into the breathing circuit will be performed.

After end of surgery, patients will be subdued to a standard weaning procedure.

Outcomes

Primary Outcome Measures

Time to extubation
Time to eye-opening
Time to discharge from OR

Secondary Outcome Measures

Postoperative recovery
Postoperative quality of recovery (PQRS) scale
Time to eligible for discharge from post-anaesthesia care unit (PACU)

Full Information

First Posted
March 3, 2017
Last Updated
December 29, 2017
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03074110
Brief Title
Isocapnic Hyperventilation - an Alternative Method
Official Title
Isocapnic Hyperventilation for Enhancing Recovery After Inhalation Anaesthesia - an Alternative Method
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Neoplasms
Keywords
Inhalation Anaesthetics, Sevoflurane, Carbon Dioxide, Hyperventilation, Anaesthesia Recovery Period, Ventilators

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isocapnic hyperventilation
Arm Type
Active Comparator
Arm Description
After end of surgery, hyperventilation and administration of a small, precalculated amount of CO2 into the breathing circuit will be performed.
Arm Title
Standard procedure
Arm Type
No Intervention
Arm Description
After end of surgery, patients will be subdued to a standard weaning procedure.
Intervention Type
Device
Intervention Name(s)
Isocapnic hyperventilation
Other Intervention Name(s)
Normocapnic hyperventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to extubation
Time Frame
5-20 minutes
Title
Time to eye-opening
Time Frame
10-25 minutes
Title
Time to discharge from OR
Time Frame
15-40 minutes
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
Postoperative quality of recovery (PQRS) scale
Time Frame
60 minutes
Title
Time to eligible for discharge from post-anaesthesia care unit (PACU)
Time Frame
1-6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27396945
Citation
Hallen K, Stenqvist O, Ricksten SE, Lindgren S. Isocapnic hyperventilation shortens washout time for sevoflurane - an experimental in vivo study. Acta Anaesthesiol Scand. 2016 Oct;60(9):1261-9. doi: 10.1111/aas.12761. Epub 2016 Jul 10.
Results Reference
background
PubMed Identifier
26688296
Citation
Hallen K, Stenqvist O, Ricksten SE, Lindgren S. A simple method for isocapnic hyperventilation evaluated in a lung model. Acta Anaesthesiol Scand. 2016 May;60(5):597-606. doi: 10.1111/aas.12674. Epub 2015 Dec 21.
Results Reference
background

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Isocapnic Hyperventilation - an Alternative Method

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