HypothermiaINHvsIVNCT02331108

A Comparison of Inhalation vs. Intravenous Induction

A study testing Selection of anesthetic induction technique in people with Hypothermia, run by Albert Einstein Healthcare Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypothermia
What is being tested?: Selection of anesthetic induction technique
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 331 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Apr 2016
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study

Who cannot join

Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

Albert EinsteinMedical Center
Philadelphia, Pennsylvania, 19141

Other trials in United States

About this study

Official title: A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

Read the detailed description

Hypothermia occurs with anesthetic induction due to redistribution hypothermia. Hypothermia has adverse effects and should be avoided or minimized. Intravenous propofol induction is the most common technique used for anesthetic induction. There is preliminary evidence that there is less redistribution hypothermia when anesthetic induction is achieved by inhalation induction compared to intravenous induction. There is not enough data to compel a change in practice patterns. This study will enroll a larger number of patients in order to provide stronger evidence that there is a significant difference between induction techniques on body temperature. Patients will be randomly assigned to two variation of inhalation induction techniques and two variations of intravenous induction. The effect on temperature between the four groups will be compared. Reducing the degree of hypothermia has the potential to decrease surgical infection rate as well as providing other benefits to patients.

Conditions: Hypothermia
Being tested: Selection of anesthetic induction technique
Medical subject headings: Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Selection of anesthetic induction techniqueDrug
Also called anesthesia, anesthetic induction, sevoflurane, propofol
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes

Study groups in NCT02331108
Study group	Role	What they receive
sevoflurane in 100% oxygen, age <56	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Receives: Drug: Selection of anesthetic induction technique
sevoflurane in 50% nitrous, age <56	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Receives: Drug: Selection of anesthetic induction technique
propofol, age <56	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Receives: Drug: Selection of anesthetic induction technique
propofol with phenylephrine, age <56	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Receives: Drug: Selection of anesthetic induction technique
sevoflurane in 100% oxygen, age >55	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55. Receives: Drug: Selection of anesthetic induction technique
sevoflurane in 50% nitrous, age >55	Active comparator	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. Receives: Drug: Selection of anesthetic induction technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Core Temperature
Core temperature at 15 minute intervals
Measured: intraoperative
Temperature Below 36.0 Degrees C
Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia
Measured: Intraoperative

Secondary outcomes (1)

Measurement of Blood Pressure
Blood pressure decrease after intravenous anesthetic induction
Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Apr 2016

First posted6 Jan 2015 (estimated)
Study startAug 2014
Primary completionOct 2015
Study completionApr 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypothermiaStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 331 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02331108
Sponsor's protocol ID: HN4613
Acronym: INHvsIV
Status last verified: Apr 2017
First submitted: 20 Nov 2014
Last updated: 17 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Roth JV, Braitman LE, Hunt LH. Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study. BMC Anesthesiol. 2019 Nov 6;19(1):203. doi: 10.1186/s12871-019-0866-8.
PubMed 31694576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypothermia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane
ClinicalTrials.gov ID: NCT02331108
Acronym / sponsor ID: INHvsIV / HN4613
Conditions: Hypothermia
Study type: Interventional
Recruitment status: Completed
Enrolment: 331 participants (actual)
Lead sponsor: Albert Einstein Healthcare NetworkUniversity, hospital or other
Study start: Aug 2014 (actual)
Primary completion: Oct 2015 (actual)
Study completion: Apr 2016 (actual)
First posted: 6 Jan 2015 (estimated)
Results: Posted 17 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
sevoflurane in 100% oxygen, age <56	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
sevoflurane in 50% nitrous, age <56	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
propofol, age <56	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
propofol with phenylephrine, age <56	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
sevoflurane in 100% oxygen, age >55	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
sevoflurane in 50% nitrous, age >55	Active comparator	Drug: Selection of anesthetic induction techniqueThe intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study

Key exclusion criteria (1 listed)

Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners

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
Selection of anesthetic induction techniqueAlso: anesthesia, anesthetic induction, sevoflurane, propofolStandard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Drug	propofol with phenylephrine, age <56, propofol, age <56, sevoflurane in 100% oxygen, age <56, sevoflurane in 100% oxygen, age >55, sevoflurane in 50% nitrous, age <56, sevoflurane in 50% nitrous, age >55

Primary outcome

Measurement of Core Temperature
Time frame: intraoperative
Core temperature at 15 minute intervals
Temperature Below 36.0 Degrees C
Time frame: Intraoperative
Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

1 secondary outcome

Measurement of Blood Pressure
Time frame: intraoperative

Results and safety

Results posted to the registry on 17 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sevoflurane in 100% Oxygen, Age <56	51	50
Sevoflurane in 50% Nitrous, Age <56	52	50
Propofol, Age <56	51	50
Propofol With Phenylephrine, Age <56	51	50
Sevoflurane in 100% Oxygen, Age >55	52	50
Sevoflurane in 50% Nitrous, Age >55	52	50

Primary outcome: Measurement of Core Temperature

Time frame: intraoperative. Mean (Standard Deviation). Unit: degree C

Measure	Sevoflurane in 100% Oxygen, Age <56 n = 50	Sevoflurane in 50% Nitrous, Age <56 n = 50	Propofol, Age <56 n = 50	Propofol With Phenylephrine, Age <56 n = 50	Sevoflurane in 100% Oxygen, Age >55 n = 50	Sevoflurane in 50% Nitrous, Age >55 n = 50
15 minute temperature	36.42 (.49)	36.44 (.44)	35.96 (.40)	36.35 (.38)	36.34 (.46)	36.41 (.52)
30 minute temperature	36.41 (.49)	36.48 (.44)	35.95 (.41)	36.36 (.40)	36.31 (.48)	36.38 (.53)
45 minute temperature	36.47 (.53)	36.50 (.43)	36.00 (.45)	36.45 (.40)	36.29 (.50)	36.41 (.57)
60 minute temperature	36.52 (.56)	36.57 (.42)	36.03 (.53)	36.51 (.43)	36.34 (.51)	36.44 (.55)

Primary outcome: Temperature Below 36.0 Degrees C

Time frame: Intraoperative. Number. Unit: Percentage

Measure	Sevoflurane in 100% Oxygen, Age <56 n = 50	Sevoflurane in 50% Nitrous, Age <56 n = 50	Propofol, Age <56 n = 50	Propofol With Phenylephrine, Age <56 n = 50	Sevoflurane in 100% Oxygen, Age >55 n = 50	Sevoflurane in 50% Nitrous, Age >55 n = 50
Value	8	8	30	8	14	14

Population analysed: Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sevoflurane in 100% Oxygen, Age <56	0 of 51 (0%)	0 of 51 (0%)	Not reported
Sevoflurane in 50% Nitrous, Age <56	0 of 52 (0%)	0 of 52 (0%)	Not reported
Propofol, Age <56	0 of 51 (0%)	0 of 51 (0%)	Not reported
Propofol With Phenylephrine, Age <56	0 of 51 (0%)	0 of 51 (0%)	Not reported
Sevoflurane in 100% Oxygen, Age >55	0 of 52 (0%)	0 of 52 (0%)	Not reported
Sevoflurane in 50% Nitrous, Age >55	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31694576Roth JV, Braitman LE, Hunt LH. Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study. BMC Anesthesiol. 2019 Nov 6;19(1):203. doi: 10.1186/s12871-019-0866-8.
Individual participant dataSharing planned: Undecided

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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.

Jonathan V Roth, MD principal investigator

Albert Einstein Healthcare Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Selection of anesthetic induction technique in people with Hypothermia, run by Albert Einstein Healthcare Network 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 1 inclusion and 1 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 17 Apr 2017. 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 17 Apr 2017). 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?

Measurement of Core Temperature (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02331108, which also lists 1 linked publication.

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 17 Apr 2017.