AtelectasisPhase 2/3NCT00715741
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
A Phase 2/3 study testing FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water, FiO2 0.3 without PEEP and FiO2 >0.9 with 3-5 cm water PEEP in people with Atelectasis, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine whether breathing high levels of oxygen during surgery affects oxygen levels after surgery. The second purpose of this study is to determine whether giving positive end expiratory pressure PEEP and high oxygen together affects patients oxygen levels after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water, FiO2 0.3 without PEEP and FiO2 >0.9 with 3-5 cm water PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2009
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years undergoing surgery under general endotracheal anesthesia at the University of Utah Hospital Operating Room and the Huntsman Cancer Hospital Operating room who will be admitted to the hospital for at least 24 hours after surgery
Who cannot join
- Major (open) abdominal surgery
- Major spine surgery
- Craniotomy surgery
- Surgeries where electrocautery or laser devices may be used near the airway (eg tracheostomy, oral surgery) because of the risk of fire with high inspired oxygen in these cases
- Procedures planned for monitored anesthesia care (MAC) or regional without general anesthesia
- Planned airway management with a laryngeal mask airway rather than an endotracheal tube
Show all 18Show fewer
- Procedures planned in the prone position because this increases atelectasis
- Planned postoperative intubation
- Planned postoperative care in the intensive care unit
- Recent (within 3 weeks) chemotherapy because of the increased risk of pulmonary oxygen toxicity
- History of bleomycin administration because of the increased risk of pulmonary oxygen toxicity
- Diagnosed Obstructive Sleep Apnea with home continuous pulmonary airway pressure (CPAP) use
- Home oxygen use
- Preoperative room air (RA) SpO2 <90%
- History of spontaneous pneumothorax
- Emergency surgery
- Pregnancy. Women of child-bearing age are routinely screened for pregnancy urine human chorionic gonadotropin, (HCG) on the morning of surgery. Patients with a positive result will be excluded from the study (and most likely will have their elective surgery cancelled).
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
The purpose of this study is to determine whether breathing high levels of oxygen during surgery affects oxygen levels after surgery. The second purpose of this study is to determine whether giving positive end expiratory pressure PEEP and high oxygen together affects patients oxygen levels after surgery.
Read the detailed description
This is a randomized, controlled, blinded trial in patients undergoing non-abdominal surgery of the effect of intraoperative increased inspired oxygen used (FiO2>0.9 vs. FiO2 = 0.3) on non-invasive oxygen saturation (pulse oximetry, SpO2) and amount of required supplemental oxygen in the post-anesthesia care unit (PACU); arterial oxygen partial pressure (PaO2) after 45 minutes in the PACU; room air SpO2 24 hours after surgery, and amount of supplemental oxygen required 24 hours after surgery. The purpose of the study is to determine whether absorption atelectasis induced by use of inspired oxygen concentrations in excess of 90% leads to a higher risk of hypoxemia, as evidenced by room air oxygen values and the need for supplemental oxygen. The objective of this study is to determine whether high inspired oxygen (>0.8), which has been demonstrated to reduce the risk of surgical site infection in patients undergoing colon surgery and other major surgical procedures has side effects that limit its use to prevent infection in lower risk operations.
There are four groups of intraoperative ventilation management in this study. Fi02 0.3 plus PEEP, Fi02 0.3 without PEEP, Fi02 greater than 0.9 plus PEEP 3 to 5 cm of water, Fi02 greater than 0.9 without PEEP.
- Conditions
- Atelectasis
- Being tested
- FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water, FiO2 0.3 without PEEP, FiO2 >0.9 with 3-5 cm water PEEP, FiO2 >0.9 without PEEP
- Keywords
- atelectasis, oxygen, saturation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm waterOther
Also called O2, Dioxygen, Sats, Oxygen Saturation
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water
FiO2 0.3 without PEEPOther
Also called O2, Dioxygen, Sats, Oxygen Saturation
FiO2 0.3 without PEEP
FiO2 >0.9 with 3-5 cm water PEEPOther
Also called O2, Dioxygen, Sats, Oxygen Saturation
FiO2 >0.9 with 3-5 cm water PEEP
FiO2 >0.9 without PEEPOther
Also called O2, Dioxygen, Sats, Oxygen Saturation
FiO2 >0.9 without PEEP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery Receives: Other: FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water |
| 2 | Active comparator | Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery Receives: Other: FiO2 0.3 without PEEP |
| 3 | Active comparator | Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery Receives: Other: FiO2 >0.9 with 3-5 cm water PEEP |
| 4 | Active comparator | Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery Receives: Other: FiO2 >0.9 without PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Requirement to Maintain SpO2>90%
Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.
Measured: 45 min after emergence (tracheal extubation)
Oxygen Requirement
amount of oxygen (LPM) required to maintain SpO2 >90%
Measured: 24 hours after tracheal extubation
Secondary outcomes (2)
Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%
Measured: 45 min after tracheal extubation
SpO2 Postoperatively
SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.
Measured: 24 hours after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 2009
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 (4)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Harriet Hopf, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715741
- Sponsor's protocol ID
- 29830
- Status last verified
- Feb 2010
- First submitted
- 10 Jul 2008
- Last updated
- 18 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
PubMed 12502973Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
PubMed 16249417Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
PubMed 15791115Myles PS, Leslie K, Chan MT, Forbes A, Paech MJ, Peyton P, Silbert BS, Pascoe E; ENIGMA Trial Group. Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial. Anesthesiology. 2007 Aug;107(2):221-31. doi: 10.1097/01.anes.0000270723.30772.da.
PubMed 17667565
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
- ClinicalTrials.gov ID
- NCT00715741
- Acronym / sponsor ID
- 29830
- Conditions
- Atelectasis
- Keywords
- atelectasis, oxygen, saturation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether breathing high levels of oxygen during surgery affects oxygen levels after surgery. The second purpose of this study is to determine whether giving positive end expiratory pressure PEEP and high oxygen together affects patients oxygen levels after surgery.
Detailed description
This is a randomized, controlled, blinded trial in patients undergoing non-abdominal surgery of the effect of intraoperative increased inspired oxygen used (FiO2>0.9 vs. FiO2 = 0.3) on non-invasive oxygen saturation (pulse oximetry, SpO2) and amount of required supplemental oxygen in the post-anesthesia care unit (PACU); arterial oxygen partial pressure (PaO2) after 45 minutes in the PACU; room air SpO2 24 hours after surgery, and amount of supplemental oxygen required 24 hours after surgery. The purpose of the study is to determine whether absorption atelectasis induced by use of inspired oxygen concentrations in excess of 90% leads to a higher risk of hypoxemia, as evidenced by room air oxygen values and the need for supplemental oxygen. The objective of this study is to determine whether high inspired oxygen (>0.8), which has been demonstrated to reduce the risk of surgical site infection in patients undergoing colon surgery and other major surgical procedures has side effects that limit its use to prevent infection in lower risk operations.
There are four groups of intraoperative ventilation management in this study. Fi02 0.3 plus PEEP, Fi02 0.3 without PEEP, Fi02 greater than 0.9 plus PEEP 3 to 5 cm of water, Fi02 greater than 0.9 without PEEP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm waterGroup 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery |
| 2 | Active comparator | Other: FiO2 0.3 without PEEPGroup 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery |
| 3 | Active comparator | Other: FiO2 >0.9 with 3-5 cm water PEEPGroup 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery |
| 4 | Active comparator | Other: FiO2 >0.9 without PEEPGroup 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-70 years undergoing surgery under general endotracheal anesthesia at the University of Utah Hospital Operating Room and the Huntsman Cancer Hospital Operating room who will be admitted to the hospital for at least 24 hours after surgery
Key exclusion criteria (18 listed)
- Major (open) abdominal surgery
- Major spine surgery
- Craniotomy surgery
- Surgeries where electrocautery or laser devices may be used near the airway (eg tracheostomy, oral surgery) because of the risk of fire with high inspired oxygen in these cases
- Procedures planned for monitored anesthesia care (MAC) or regional without general anesthesia
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 |
|---|---|---|
| FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm waterAlso: O2, Dioxygen, Sats, Oxygen SaturationFiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water | Other | 1 |
| FiO2 0.3 without PEEPAlso: O2, Dioxygen, Sats, Oxygen SaturationFiO2 0.3 without PEEP | Other | 2 |
| FiO2 >0.9 with 3-5 cm water PEEPAlso: O2, Dioxygen, Sats, Oxygen SaturationFiO2 >0.9 with 3-5 cm water PEEP | Other | 3 |
| FiO2 >0.9 without PEEPAlso: O2, Dioxygen, Sats, Oxygen SaturationFiO2 >0.9 without PEEP | Other | 4 |
Primary outcome
Oxygen Requirement to Maintain SpO2>90%
Time frame: 45 min after emergence (tracheal extubation)
Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.
Oxygen Requirement
Time frame: 24 hours after tracheal extubation
amount of oxygen (LPM) required to maintain SpO2 >90%
2 secondary outcomes
Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
Time frame: 45 min after tracheal extubation
SpO2 Postoperatively
Time frame: 24 hours after tracheal extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12502973Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
- Background: PubMed 16249417Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
- Background: PubMed 15791115Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
- Background: PubMed 17667565Myles PS, Leslie K, Chan MT, Forbes A, Paech MJ, Peyton P, Silbert BS, Pascoe E; ENIGMA Trial Group. Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial. Anesthesiology. 2007 Aug;107(2):221-31. doi: 10.1097/01.anes.0000270723.30772.da.
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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.
Harriet Hopf, M.D. 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 Phase 2/3 study testing FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water, FiO2 0.3 without PEEP and FiO2 >0.9 with 3-5 cm water PEEP in people with Atelectasis, 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 1 inclusion and 18 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 18 Feb 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2010). 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?
Oxygen Requirement to Maintain SpO2>90% (time frame: 45 min after emergence (tracheal extubation)). 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 NCT00715741, which also lists 4 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 18 Feb 2010.