Postoperative CareNCT01191528
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)
An observational study of Postoperative Care, run by Allenmore Hospital at 1 site in United States.
Trial summary
To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care
- What is being tested?
- capnostream 20, Oridian Medical 1987 ltd, Needham MA
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2010
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience sample post-operative in-patients admitted to 2 East at Allenmore Hospital/multicare Health system a 75 bed community facility.
Who may be able to join
- Age greater than 18
- Increased Body Mass Index (BMI) > 31
- History of chronic obstructive pulmonary disease (COPD)
- History of Sleep Apnea
Who cannot join
- Respiratory failure
- Isolation requirements
- Surgical patients admitted to 2 West or ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index in Adult Post-operative Patients
To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.
Read the detailed description
A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night.
Subjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.
- Conditions
- Postoperative Care
- Being tested
- capnostream 20, Oridian Medical 1987 ltd, Needham MA
- Keywords
- Adult, Post, operative, oximetry, capnometry, Integrated, Pulmonary, Index, End-tidal, Monitoring Respiratory status, post-operative
- Medical subject headings
- Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capnostream 20, Oridian Medical 1987 ltd, Needham MADevice
Also called OxiMax Nellcor, Covidien, Capnoline, Oridion Medical
Oxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor.
End-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allenmore Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Julie M Northrup, ADN, BC, Principal investigator, Multicare Health System-Allenmore HospitalJennifer Spotted-Horse, MS,BSN,OCN, Principal investigator, Multicare Health System-Allenmore HospitalDawn Fox, RN, Principal investigator, Multicare Health System-Allenmore HosptialDavid Lechich, RN, Principal investigator, Multicare Health System-Allenmore HospitalJoan Fortune, RN, Principal investigator, Multicare Health System Allenmore HospitalKaty Rogers, RN, Principal investigator, Multicare Health System, Allenmore HospitalLynn Arnold, RN, Principal investigator, Multicare Health System Allenmore HospitalLisa Ettlin-Porter, BSN,RN,CCRN, Principal investigator, Multicare Health System Allenmore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191528
- Sponsor's protocol ID
- AH2ESCAP
- Status last verified
- Dec 2010
- First submitted
- 30 Aug 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index in Adult Post-operative Patients
- ClinicalTrials.gov ID
- NCT01191528
- Acronym / sponsor ID
- AH2ESCAP
- Conditions
- Postoperative Care
- Keywords
- Adult, Post, operative, oximetry, capnometry, Integrated, Pulmonary, Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allenmore HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Aug 2010 (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.
To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.
Detailed description
A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night.
Subjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample post-operative in-patients admitted to 2 East at Allenmore Hospital/multicare Health system a 75 bed community facility.
Key inclusion criteria (4 listed)
- Age greater than 18
- Increased Body Mass Index (BMI) > 31
- History of chronic obstructive pulmonary disease (COPD)
- History of Sleep Apnea
Key exclusion criteria (3 listed)
- Respiratory failure
- Isolation requirements
- Surgical patients admitted to 2 West or ICU
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 |
|---|---|---|
| capnostream 20, Oridian Medical 1987 ltd, Needham MAAlso: OxiMax Nellcor, Covidien, Capnoline, Oridion MedicalOxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor. End-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals. | Device | – |
Primary outcome
Not reported in the source record.
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 13 Dec 2010.
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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.
Julie M Northrup, ADN, BC principal investigator
Multicare Health System-Allenmore Hospital
Jennifer Spotted-Horse, MS,BSN,OCN principal investigator
Multicare Health System-Allenmore Hospital
Dawn Fox, RN principal investigator
Multicare Health System-Allenmore Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Care, run by Allenmore Hospital 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 3 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 13 Dec 2010. 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.
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 13 Dec 2010.