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Changes in lung function en exhaled breath after exposure to oxygen at high atmospheric pressure.


- candidate number10446
- NTR NumberNTR3106
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-okt-2011
- Secondary IDsNL35768.018.11 CCMO
- Public TitleChanges in lung function en exhaled breath after exposure to oxygen at high atmospheric pressure.
- Scientific TitleChanges in VC, DLCO, DLNO and exhaled breath after an one-hour oxygen dive with a PO2 of 190 kPa as an indication for pulmonary oxygen toxicity.
- ACRONYMpulmonary functional changes after an oxygen dive
- hypothesisBreathing oxygen with a partial pressure (PO2 ) of more than 50 kPa can eventually lead to pulmonary oxygen intoxication (POT). Nowadays, changes in lung function are used as an indicator for the development of POT. Most mentioned indicator is the decrease in vital capacity (VC). However, recent publications indicates that nor VC but diffusing capacity for carbon monoxide could be a more sensitive indicator. In this study we want to invest if this statement is true. Beside VC and DLco one can also use diffusing capacity for nitric oxide (DLno) as this measure the alterations in the alveolocapillary membrane much better than DLco. Recently, it is also possible to examine the change in volatile organic components(VOC) in exhaled breath. As pulmonary oxygen toxicity has similarities with alveolar inflammation it is feasible that one could also find an alteration in VOC of exhaled breath. Our hypotheses is that after breathing oxygen with a PO2 = 190 kPa for 1 h changes in DLco, DLno and VOC's in exhaled breath (EB) can be found while VC will be unchanged.
- Healt Condition(s) or Problem(s) studiedPulmonary oxygen toxicity, Diffusing capacity, Spirometry, Exhaled breath
- Inclusion criteria1. Adult males;
2. Professional divers;
3. Fit to dive;
4. Certified Oxygen divers or those who were granted dispensation for oxygen diving;
5. FEV1/SVC minimal 70 (absolute);
6. DLco % reference > 70%.
- Exclusion criteria1. If one of the inclusion criteria is not met;
2. Recent lower respiratory tract infection and/or flue;
3. Daily use of alcoholic beverages.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-okt-2012
- Target number of participants25
- InterventionsEvery subject will perform one dive with air and one with 100% oxygen. These dives will be done in random order.
- Primary outcomeChanges in DLno and DLco compared to baseline after air and oxygen dives.
- Secondary outcome1. Changes in VC, Dm, VC, EB compared to baseline after air and oxygen dives;
2. Changes in oxidative stress status compared to baseline after air and oxygen dives.
- Timepoints1. Pre (baseline);
2. Post;
3. Post + 2hr;
4. Post + 4hr;
5. Post + 8hr;
6. Post +22 hr.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES P.J.A.M. Ooij, van
- CONTACT for SCIENTIFIC QUERIES P.J.A.M. Ooij, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Royal Netherlands Navy
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD18-okt-2011 - 26-okt-2011


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