HypercapniaNCT00708526
Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
A study testing Quick Emergence Device in people with Hypercapnia, run by University of Utah at 1 site in United States.
Trial summary
The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnia
- What is being tested?
- Quick Emergence Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- ASA class I-III
- both genders
- scheduled to undergo eye surgery at the Moran Hospital.
Who cannot join
- a history of renal or hepatic disease,
- chronic alcohol or drug abuse,
- disabling neuropsychiatric disorder,
- hypersensitivity or unusual response to other halogenated anesthetics,
- pulmonary hypertension,
- increased intracranial pressure,
Show all 15Show fewer
- seizure disorder
- personal/familial history of malignant hyperthermia.
- currently being treated with known hepatic enzyme-inducing drugs (e.g., phenobarbital, dilantin or isoniazid)
- or with drugs known to alter anesthetic requirements (e.g., opiates, clonidine, alpha2 agonists, alcohol, anticonvulsants, antidepressants, barbiturates, benzodiazepines or other tranquilizers).
- intolerance to non-steroidal anti-inflammatories.
- have received general anesthesia within the previous 7 days,
- received any investigational drug within the previous 28 days,
- participated in a previous isoflurane or desflurane study
- Female subjects can be neither pregnant nor breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia.
Read the detailed description
Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. In our first clinical study with isoflurane we confirmed that the time from turning off the vaporizer to opening of eyes was shortened by an average of 62% when the minute ventilation was elevated and the end tidal carbon dioxide concentration was kept at 52 mmHg rather than 28 mmHg during emergence. In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane. The benefits of accelerating subject recovery in the operating room may extend to the entire recovery period if the subject is more alert and easier to care for when they arrive in the post anesthesia care unit.
- Conditions
- Hypercapnia
- Being tested
- standard of care for phase one anesthesia care, Quick Emergence Device
- Keywords
- hypercapnia, hyperpnoea, accelerated recovery
- Medical subject headings
- Hypercapnia, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care for phase one anesthesia careOther
Patients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery.
Quick Emergence DeviceDevice
Also called QED-100 from Anecare Inc
The Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Recovery | Experimental | Quick Emergence Device is in place for phase 1 anesthesia recovery Receives: Device: Quick Emergence Device |
| Standard of care | Other | Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia Receives: Other: standard of care for phase one anesthesia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery From Anesthesia
average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).
Measured: up to 2 hours
Secondary outcomes (1)
Return of Cognitive Function
average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Anecare
- Responsible party
- Sponsor
- Investigators
- Dwayne Westenskow, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708526
- Sponsor's protocol ID
- 26111
- Status last verified
- Nov 2022
- First submitted
- 30 Jun 2008
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
- ClinicalTrials.gov ID
- NCT00708526
- Acronym / sponsor ID
- 26111
- Conditions
- Hypercapnia
- Keywords
- hypercapnia, hyperpnoea, accelerated recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Anecare
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Posted 19 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia.
Detailed description
Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. In our first clinical study with isoflurane we confirmed that the time from turning off the vaporizer to opening of eyes was shortened by an average of 62% when the minute ventilation was elevated and the end tidal carbon dioxide concentration was kept at 52 mmHg rather than 28 mmHg during emergence. In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane. The benefits of accelerating subject recovery in the operating room may extend to the entire recovery period if the subject is more alert and easier to care for when they arrive in the post anesthesia care unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Recovery | Experimental | Device: Quick Emergence DeviceQuick Emergence Device is in place for phase 1 anesthesia recovery |
| Standard of care | Other | Other: standard of care for phase one anesthesia careTidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults
- ASA class I-III
- both genders
- scheduled to undergo eye surgery at the Moran Hospital.
Key exclusion criteria (15 listed)
- a history of renal or hepatic disease,
- chronic alcohol or drug abuse,
- disabling neuropsychiatric disorder,
- hypersensitivity or unusual response to other halogenated anesthetics,
- pulmonary hypertension,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of care for phase one anesthesia carePatients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery. | Other | Standard of care |
| Quick Emergence DeviceAlso: QED-100 from Anecare IncThe Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg. | Device | Phase 1 Recovery |
Primary outcome
Recovery From Anesthesia
Time frame: up to 2 hours
average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).
1 secondary outcome
Return of Cognitive Function
Time frame: up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwayne Westenskow principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quick Emergence Device in people with Hypercapnia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery From Anesthesia (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.