Isocapnic Hyperventilation - an Alternative Method

NCT03074110 | Completed

• 1 other identifier: GLS-588681
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Neoplasms

Keywords

Inhalation Anaesthetics, Sevoflurane; Carbon Dioxide; Hyperventilation; Anaesthesia Recovery Period; Ventilators

Outcome Measures

Primary Outcomes (3)

• Time to extubation

  5-20 minutes

• Time to eye-opening

  10-25 minutes

• Time to discharge from OR

  15-40 minutes

Secondary Outcomes (2)

• Postoperative recovery

  60 minutes

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

  1-6 hours

Study Arms (2)

Isocapnic hyperventilation

ACTIVE COMPARATOR

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

Device: Isocapnic hyperventilation

Standard procedure

NO INTERVENTION

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

Interventions

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.

Also known as: Normocapnic hyperventilation

Isocapnic hyperventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe pulmonary or circulatory disease

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• 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.

  PMID: 27396945 BACKGROUND

• 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.

  PMID: 26688296 BACKGROUND

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Hyperventilation

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: November 11, 2016
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)