LaparotomyPhase 4NCT00637936
Respiratory Effects of Perioperative Oxygen During General Anaesthesia
A Phase 4 study testing Oxygen in people with Laparotomy, run by University of Copenhagen.
Trial summary
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Laparatomy, elective
Who cannot join
- Inability to give informed consent
- Chemotherapy within 3 months
- Other surgery within 30 days(except surgery in local anaesthesia)
- Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)
About this study
Official title: Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery.
Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration.
Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.
- Conditions
- Laparotomy
- Being tested
- Oxygen
- Keywords
- perioperative oxygen, respiratory complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Inspiratory fraction during anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group 1 is given 30% oxygen during and 2 hours after surgery Receives: Drug: Oxygen |
| 2 | Active comparator | Group 2 is given 80% during and 2 hours after surgery. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2/FiO2-index during general anaesthesia.
Measured: End of surgery.
Secondary outcomes (5)
Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery.
Measured: 1½ hour after surgery.
Atelectasis and Pneumonia
Measured: 14 days after surgery
Arterial oxygen saturation
Measured: 2 hours and 3 days after surgery.
Change in functional residual capacity (FRC)
Measured: 2 hours after surgery.
Change in effective pulmonary bloodflow
Measured: 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Investigators
- Christian S Meyhoff, MD, Study director, Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkLars S Rasmussen, MD, PHD, DMSC, Study chair, Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkSteen Henneberg, MD,DMSC, Study director, Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkAnne Kathrine Stæhr, Principal investigator, Detp. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkPoul L Christensen, MD, Study director, Dept. of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637936
- Sponsor's protocol ID
- KF 02 306766-B
- Status last verified
- Jan 2009
- First submitted
- 10 Mar 2008
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Staehr AK, Meyhoff CS, Henneberg SW, Christensen PL, Rasmussen LS. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial. BMC Res Notes. 2012 Jul 28;5:383. doi: 10.1186/1756-0500-5-383.
PubMed 22840231
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy
- ClinicalTrials.gov ID
- NCT00637936
- Acronym / sponsor ID
- KF 02 306766-B
- Conditions
- Laparotomy
- Keywords
- perioperative oxygen, respiratory complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Mar 2008 (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.
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery.
Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration.
Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: OxygenGroup 1 is given 30% oxygen during and 2 hours after surgery |
| 2 | Active comparator | Drug: OxygenGroup 2 is given 80% during and 2 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Laparatomy, elective
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Chemotherapy within 3 months
- Other surgery within 30 days(except surgery in local anaesthesia)
- Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)
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 |
|---|---|---|
| OxygenInspiratory fraction during anaesthesia | Drug | 1, 2 |
Primary outcome
Change in PaO2/FiO2-index during general anaesthesia.
Time frame: End of surgery.
5 secondary outcomes
Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery.
Time frame: 1½ hour after surgery.
Atelectasis and Pneumonia
Time frame: 14 days after surgery
Arterial oxygen saturation
Time frame: 2 hours and 3 days after surgery.
Change in functional residual capacity (FRC)
Time frame: 2 hours after surgery.
Change in effective pulmonary bloodflow
Time frame: 2 hours after surgery.
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 12 Jan 2009.
- Derived from this study: PubMed 22840231Staehr AK, Meyhoff CS, Henneberg SW, Christensen PL, Rasmussen LS. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial. BMC Res Notes. 2012 Jul 28;5:383. doi: 10.1186/1756-0500-5-383.
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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.
Christian S Meyhoff, MD study director
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Lars S Rasmussen, MD, PHD, DMSC study chair
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Steen Henneberg, MD,DMSC study director
Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen in people with Laparotomy, run by University of Copenhagen.
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 2 inclusion and 4 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 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in PaO2/FiO2-index during general anaesthesia. (time frame: End of surgery.). 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 NCT00637936, 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 12 Jan 2009.