Pulmonary FunctiontidalvolumeNCT00795964
Influence of Tidal Volume on Postoperative Pulmonary Function
A study testing Randomized application of intraoperative tidal volume in people with Pulmonary Function, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Function
- What is being tested?
- Randomized application of intraoperative tidal volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Sep 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- age ≥ 50 years and ASA classification ≥ II
- elective upper abdominal surgery of at least 3 hours duration
- general anaesthesia plus epidural anaesthesia.
Who cannot join
- < 18 years of age
- impaired mental state
- unwillingness to participate
- pregnancy
- duration of surgery < 3 hours
- ASA physical status ≥ IV
- increased intracranial pressure
- neuromuscular disease that impairs spontaneous breathing
Trial locations and contacts
1 site in 1 country.
About this study
Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.
- Conditions
- Pulmonary Function
- Being tested
- Randomized application of intraoperative tidal volume
- Keywords
- tidal volume, predicted body weight, lung function, respiratory outcome, Respiratory Function Tests, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized application of intraoperative tidal volumeOther
Also called Respiratory management
intraoperative mechanical ventilation with 6 ml/kg predicted body weight
Randomized application of intraoperative tidal volumeOther
Also called Respiratory management
intraoperative mechanical ventilation with 12 ml/kg predicted body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | intraoperative mechanical ventilation with 6 ml/kg predicted body weight Receives: Other: Randomized application of intraoperative tidal volume |
| 2 | Active comparator | intraoperative mechanical ventilation with 12 ml/kg predicted body weight Receives: Other: Randomized application of intraoperative tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function as assessed by spirometry
Measured: 1 year
Secondary outcomes (5)
lung function as assessed by blood gas analysis
Measured: 1 year
time till hospital discharge
Measured: 1 year
postoperative organ dysfunction
Measured: 1 year
postoperative chest x-rays
Measured: 1 year
time till mobilisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Investigators
- Tanja A Meyer-Treschan, MD, Principal investigator, Department of Anesthesiology at Duesseldorf University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795964
- Sponsor's protocol ID
- Intraoperative tidalvolume-25
- Acronym
- tidalvolume
- Status last verified
- Sep 2010
- First submitted
- 20 Nov 2008
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tidal Volume on Postoperative Pulmonary Function
- ClinicalTrials.gov ID
- NCT00795964
- Acronym / sponsor ID
- tidalvolume / Intraoperative tidalvolume-25
- Conditions
- Pulmonary Function
- Keywords
- tidal volume, predicted body weight, lung function, respiratory outcome, Respiratory Function Tests, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Nov 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.
Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Randomized application of intraoperative tidal volumeintraoperative mechanical ventilation with 6 ml/kg predicted body weight |
| 2 | Active comparator | Other: Randomized application of intraoperative tidal volumeintraoperative mechanical ventilation with 12 ml/kg predicted body weight |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent
- age ≥ 50 years and ASA classification ≥ II
- elective upper abdominal surgery of at least 3 hours duration
- general anaesthesia plus epidural anaesthesia.
Key exclusion criteria (8 listed)
- < 18 years of age
- impaired mental state
- unwillingness to participate
- pregnancy
- duration of surgery < 3 hours
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 |
|---|---|---|
| Randomized application of intraoperative tidal volumeAlso: Respiratory managementintraoperative mechanical ventilation with 6 ml/kg predicted body weight | Other | 1 |
| Randomized application of intraoperative tidal volumeAlso: Respiratory managementintraoperative mechanical ventilation with 12 ml/kg predicted body weight | Other | 2 |
Primary outcome
Lung function as assessed by spirometry
Time frame: 1 year
5 secondary outcomes
lung function as assessed by blood gas analysis
Time frame: 1 year
time till hospital discharge
Time frame: 1 year
postoperative organ dysfunction
Time frame: 1 year
postoperative chest x-rays
Time frame: 1 year
time till mobilisation
Time frame: 1 year
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 24 Sep 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.
Tanja A Meyer-Treschan, MD principal investigator
Department of Anesthesiology at Duesseldorf University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized application of intraoperative tidal volume in people with Pulmonary Function, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 24 Sep 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 Germany. 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?
Lung function as assessed by spirometry (time frame: 1 year). 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 24 Sep 2010; AzTrials last refreshed its copy on 31 Oct 2026.