SurgeryRIP03NCT01733446
A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration
A study testing Continuation of High Frequency Jet Ventilation (HFJV) in people with Surgery and Anesthesia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Anesthesia
- What is being tested?
- Continuation of High Frequency Jet Ventilation (HFJV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female patients ages > 18 to < 80
- Scheduled for procedures under general anesthesia with jet ventilation
- Sign informed consent
- Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)
Who cannot join
- Absence of informed consent
- No planned use intra-operative use of jet ventilation
- Known difficulties with jet ventilation during prior surgical procedures
- Emergency surgery
- Baseline (oxygen saturation)SpO2 <92% on room air
- BMI > 50
- Pregnant or lactating females
- Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration With Respiratory Inductance Plethysmography (RIP) During High Frequency Jet Ventilation (HFJV) Under General Anesthesia
The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event.
The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.
Read the detailed description
The present study will use non-invasive respiratory inductance plethysmography(RIP) and transcutaneous carbon dioxide measurement to compare recovery of respiration under constant Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet ventilation HFJV (study method) with recovery of respiration during rising and apnea (current standard).
The investigators hypothesize that the prolonged abdominal expiration that we observed during recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2) levels.
- Conditions
- Surgery, Anesthesia
- Being tested
- Continuation of High Frequency Jet Ventilation (HFJV)
- Keywords
- High frequency jet ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuation of High Frequency Jet Ventilation (HFJV)Other
In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.
| Study group | Role | What they receive |
|---|---|---|
| Standard anesthesia regimen | No intervention | Positive pressure ventilation will be stopped at the same time infusions of anesthetic agents and spontaneous ventilation employed until emergence from anesthesia is observed. (This is standard protocol for everyday anesthesia management of this population.) |
| Continuation of High Frequency Jet Ventilation ( HFJV) | Experimental | In Group B after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence. Receives: Other: Continuation of High Frequency Jet Ventilation (HFJV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous breathing
The primary variable will be first breath as detected by Respiratory Inductance Plethysmography (RIP. This will occur in the operating room at the end of the surgery and anesthesia.)
Measured: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua H Atkins, MD PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733446
- Sponsor's protocol ID
- 816280
- Acronym
- RIP03
- Status last verified
- Apr 2018
- First submitted
- 2 Oct 2012
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration With Respiratory Inductance Plethysmography (RIP) During High Frequency Jet Ventilation (HFJV) Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01733446
- Acronym / sponsor ID
- RIP03 / 816280
- Conditions
- Surgery, Anesthesia
- Keywords
- High frequency jet ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event.
The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.
Detailed description
The present study will use non-invasive respiratory inductance plethysmography(RIP) and transcutaneous carbon dioxide measurement to compare recovery of respiration under constant Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet ventilation HFJV (study method) with recovery of respiration during rising and apnea (current standard).
The investigators hypothesize that the prolonged abdominal expiration that we observed during recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2) levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard anesthesia regimen | No intervention | –Positive pressure ventilation will be stopped at the same time infusions of anesthetic agents and spontaneous ventilation employed until emergence from anesthesia is observed. (This is standard protocol for everyday anesthesia management of this population.) |
| Continuation of High Frequency Jet Ventilation ( HFJV) | Experimental | Other: Continuation of High Frequency Jet Ventilation (HFJV)In Group B after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female patients ages > 18 to < 80
- Scheduled for procedures under general anesthesia with jet ventilation
- Sign informed consent
- Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)
Key exclusion criteria (8 listed)
- Absence of informed consent
- No planned use intra-operative use of jet ventilation
- Known difficulties with jet ventilation during prior surgical procedures
- Emergency surgery
- Baseline (oxygen saturation)SpO2 <92% on room air
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 |
|---|---|---|
| Continuation of High Frequency Jet Ventilation (HFJV)In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence. | Other | Continuation of High Frequency Jet Ventilation ( HFJV) |
Primary outcome
spontaneous breathing
Time frame: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath
The primary variable will be first breath as detected by Respiratory Inductance Plethysmography (RIP. This will occur in the operating room at the end of the surgery and anesthesia.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
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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.
Joshua H Atkins, MD PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuation of High Frequency Jet Ventilation (HFJV) in people with Surgery and Anesthesia, run by University of Pennsylvania 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 8 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 23 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
spontaneous breathing (time frame: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath). 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 23 Apr 2018.