HypoventilationNCT06239831
Postoperative Respiratory and Activity Monitoring
An observational study of Hypoventilation and Hypoxemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypoventilation, Hypoxemia, Postoperative Pulmonary Complications
- What is being tested?
- ExSpiron and ActivPAL Monitors
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 22 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 undergoing abdominal surgery at the University of Colorado Health Hospital (UCHealth) that it high-risk for postoperative pulmonary complications (PPCs).
Who may be able to join
- Must be 18 or older
- Must be undergoing abdominal surgery
- Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)
Who cannot join
- Anyone under 18
- Anyone not undergoing abdominal surgery
- Anyone that is not high-risk for PPCs (ARISCAT score less than 26)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Health
Aurora, Colorado, 80045
Emily G. Helmer, 303-724-2938, emily.helmer@cuanschutz.edu
Ana Fernandez-Bustamante, MD, PhD
About this study
This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.
Read the detailed description
Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.
Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.
- Being tested
- ExSpiron and ActivPAL Monitors
- Keywords
- hypoventilation, postoperative activity, abdominal surgery, mobilization, predicted minute ventilation (MVPred), accelerometer, chest monitor, postoperative pulmonary complications, surgical outcomes
- Medical subject headings
- Hypoventilation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExSpiron and ActivPAL MonitorsDevice
ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh
| Study group | Role | What they receive |
|---|---|---|
| Postoperative monitoring | ActivPAL accelerometer will be placed on the chest and thigh, an ExSpiron monitor placed on the chest, and the patient will be observed for three days, until fully ambulatory (able to walk 30 meters without assistance with or without a walker), or until discharge; whichever comes earlier. Receives: Device: ExSpiron and ActivPAL Monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoventilation
Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume
Measured: First 3 postoperative days
Secondary outcomes (31)
Variability of MV
Variability of minute ventilation (MV)
Measured: Through postoperative day 3
Variability of VT
Variability of tidal volume (VT)
Measured: Through postoperative day 3
Variability of RR
Variability of respiratory rate (RR)
Measured: Through postoperative day 3
Events of Low MV
Total number of events of low minute ventilation (MV)
Measured: Through postoperative day 3
Events of Low VT
Total number of events of low tidal volume (VT)
Measured: Through postoperative day 3
Events of Low RR
Total number of events of low respiratory rate (RR)
Measured: Through postoperative day 3
Percentage of time free of low or high MV
The percentage of hours per day free of any low or high minute ventilation (MV)
Measured: Through postoperative day 3
Percentage of time free of low or high VT
The percentage of hours per day free of any low or high tidal volume (VT)
Measured: Through postoperative day 3
Percentage of time free of low or high RR
The percentage of hours per day free of any low or high resting rate (RR).
Measured: Through postoperative day 3
Duration of low MV
Duration of low minute ventilation (MV)
Measured: Through postoperative day 3
Duration of low VT
Duration of low tidal volume (VT)
Measured: Through postoperative day 3
Duration of low RR
Duration of low respiratory rate (RR)
Measured: Through postoperative day 3
Duration of high MV
Duration of low or high minute ventilation (MV)
Measured: Through postoperative day 3
Duration of high TV
Duration of high tidal volume (VT)
Measured: Through postoperative day 3
Duration of high RR
Duration of high respiratory rate (RR)
Measured: Through postoperative day 3
Postoperative Pulmonary Complication (PPC) Incidence
Incidence of Postoperative Pulmonary Complications, or PPCs
Measured: Through postoperative day 7
Postoperative Pulmonary Complication (PPC) Severity
Postoperative Pulmonary Complications, or PPCs, will be observed in their severity. PPC severity is defined as the most serious from Grade 0 (none) to Grade 4 (severe)
Measured: Through postoperative day 7
Time After Surgery to Sitting
Time it takes for the patient to sit in a chair after surgery
Measured: Through postoperative day 3
Time After Surgery to Ambulating
Time it takes for the patient to ambulate with and without help
Measured: Through postoperative day 3
Total Minutes Walking
Patient's total minutes of walking
Measured: Through postoperative day 3
Total Walking Distance
Patient's total walking distance (in meters)
Measured: Through postoperative day 3
Frequency of Ambulation
How many times the patient gets up to ambulate
Measured: Through postoperative day 3
Time Spent in Bed
After the surgery, the patient's minutes spent in bed
Measured: Through postoperative day 3
Time Spent in Sitting
After the surgery, the patient's minutes spent sitting
Measured: Through postoperative day 3
Time Spent Standing
After the surgery, the patient's minutes spent standing
Measured: Through postoperative day 3
Time Spent Walking
After the surgery, the patient's minutes spent walking
Measured: Through postoperative day 3
Average Speed of Ambulation
After the surgery, the patient's average speed of ambulating
Measured: Through postoperative day 3
First Postoperative Day Achieving Independent Ambulation
After the surgery, the patient's first day of ambulating by his or herself for 30 meters
Measured: Through postoperative day 3
Metabolic Equivalent of Task (MET) Score of Physical Activity
After the surgery, the patient's intensity of physical activity measured in METs
Measured: Through postoperative day 3
Other complications
Incidence of any non-respiratory complications
Measured: Through postoperative day 7
Adverse events
Incidence of any adverse events
Measured: Through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start22 Dec 2022
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Ana Fernandez-Bustamante, MD, PhD, Principal investigator, University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239831
- Sponsor's protocol ID
- 22-2268
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023.
PubMed 37023031Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
PubMed 8770719Fernandez-Perez ER, Sprung J, Afessa B, Warner DO, Vachon CM, Schroeder DR, Brown DR, Hubmayr RD, Gajic O. Intraoperative ventilator settings and acute lung injury after elective surgery: a nested case control study. Thorax. 2009 Feb;64(2):121-7. doi: 10.1136/thx.2008.102228. Epub 2008 Nov 6.
PubMed 18988659Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
PubMed 21045639Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.
PubMed 21572323Nijbroek SG, Schultz MJ, Hemmes SNT. Prediction of postoperative pulmonary complications. Curr Opin Anaesthesiol. 2019 Jun;32(3):443-451. doi: 10.1097/ACO.0000000000000730.
PubMed 30893115Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
PubMed 24755786Sabate S, Mazo V, Canet J. Predicting postoperative pulmonary complications: implications for outcomes and costs. Curr Opin Anaesthesiol. 2014 Apr;27(2):201-9. doi: 10.1097/ACO.0000000000000045.
PubMed 24419159Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
PubMed 23571640LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646.
PubMed 28633157Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
PubMed 24894577Milot J, Perron J, Lacasse Y, Letourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. doi: 10.1378/chest.119.3.884.
PubMed 11243972Blum JM, Stentz MJ, Dechert R, Jewell E, Engoren M, Rosenberg AL, Park PK. Preoperative and intraoperative predictors of postoperative acute respiratory distress syndrome in a general surgical population. Anesthesiology. 2013 Jan;118(1):19-29. doi: 10.1097/ALN.0b013e3182794975.
PubMed 23221870Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
PubMed 27829093
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Respiratory and Activity Monitoring
- ClinicalTrials.gov ID
- NCT06239831
- Acronym / sponsor ID
- 22-2268
- Keywords
- hypoventilation, postoperative activity, abdominal surgery, mobilization, predicted minute ventilation (MVPred), accelerometer, chest monitor, postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Jun 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- 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.
This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.
Detailed description
Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.
Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative monitoring | – | Device: ExSpiron and ActivPAL MonitorsActivPAL accelerometer will be placed on the chest and thigh, an ExSpiron monitor placed on the chest, and the patient will be observed for three days, until fully ambulatory (able to walk 30 meters without assistance with or without a walker), or until discharge; whichever comes earlier. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 undergoing abdominal surgery at the University of Colorado Health Hospital (UCHealth) that it high-risk for postoperative pulmonary complications (PPCs).
Key inclusion criteria (3 listed)
- Must be 18 or older
- Must be undergoing abdominal surgery
- Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)
Key exclusion criteria (3 listed)
- Anyone under 18
- Anyone not undergoing abdominal surgery
- Anyone that is not high-risk for PPCs (ARISCAT score less than 26)
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 |
|---|---|---|
| ExSpiron and ActivPAL MonitorsExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh | Device | Postoperative monitoring |
Primary outcome
Hypoventilation
Time frame: First 3 postoperative days
Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume
31 secondary outcomes
Variability of MV
Time frame: Through postoperative day 3
Variability of VT
Time frame: Through postoperative day 3
Variability of RR
Time frame: Through postoperative day 3
Events of Low MV
Time frame: Through postoperative day 3
Events of Low VT
Time frame: Through postoperative day 3
Events of Low RR
Time frame: Through postoperative day 3
Percentage of time free of low or high MV
Time frame: Through postoperative day 3
Percentage of time free of low or high VT
Time frame: Through postoperative day 3
Percentage of time free of low or high RR
Time frame: Through postoperative day 3
Duration of low MV
Time frame: Through postoperative day 3
Duration of low VT
Time frame: Through postoperative day 3
Duration of low RR
Time frame: Through postoperative day 3
Duration of high MV
Time frame: Through postoperative day 3
Duration of high TV
Time frame: Through postoperative day 3
Duration of high RR
Time frame: Through postoperative day 3
Postoperative Pulmonary Complication (PPC) Incidence
Time frame: Through postoperative day 7
Postoperative Pulmonary Complication (PPC) Severity
Time frame: Through postoperative day 7
Time After Surgery to Sitting
Time frame: Through postoperative day 3
Time After Surgery to Ambulating
Time frame: Through postoperative day 3
Total Minutes Walking
Time frame: Through postoperative day 3
Total Walking Distance
Time frame: Through postoperative day 3
Frequency of Ambulation
Time frame: Through postoperative day 3
Time Spent in Bed
Time frame: Through postoperative day 3
Time Spent in Sitting
Time frame: Through postoperative day 3
Time Spent Standing
Time frame: Through postoperative day 3
Time Spent Walking
Time frame: Through postoperative day 3
Average Speed of Ambulation
Time frame: Through postoperative day 3
First Postoperative Day Achieving Independent Ambulation
Time frame: Through postoperative day 3
Metabolic Equivalent of Task (MET) Score of Physical Activity
Time frame: Through postoperative day 3
Other complications
Time frame: Through postoperative day 7
Adverse events
Time frame: Through postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 37023031Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023.
- Background: PubMed 8770719Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
- Background: PubMed 18988659Fernandez-Perez ER, Sprung J, Afessa B, Warner DO, Vachon CM, Schroeder DR, Brown DR, Hubmayr RD, Gajic O. Intraoperative ventilator settings and acute lung injury after elective surgery: a nested case control study. Thorax. 2009 Feb;64(2):121-7. doi: 10.1136/thx.2008.102228. Epub 2008 Nov 6.
- Background: PubMed 21045639Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Background: PubMed 21572323Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.
- Background: PubMed 30893115Nijbroek SG, Schultz MJ, Hemmes SNT. Prediction of postoperative pulmonary complications. Curr Opin Anaesthesiol. 2019 Jun;32(3):443-451. doi: 10.1097/ACO.0000000000000730.
- Background: PubMed 24755786Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
- Background: PubMed 24419159Sabate S, Mazo V, Canet J. Predicting postoperative pulmonary complications: implications for outcomes and costs. Curr Opin Anaesthesiol. 2014 Apr;27(2):201-9. doi: 10.1097/ACO.0000000000000045.
- Background: PubMed 23571640Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
- Background: PubMed 28633157LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646.
- Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- Background: PubMed 24894577PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
- Individual participant dataSharing planned: No
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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.
Ana Fernandez-Bustamante, MD, PhD principal investigator
University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital
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 Hypoventilation and Hypoxemia, run by University of Colorado, Denver 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 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily G. Helmer ((303)-724-2938, emily.helmer@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoventilation (time frame: First 3 postoperative days). 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 NCT06239831, which also lists 61 linked publications.
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 30 Apr 2025.