Oxygen Inhalation Therapy Clinical Trial
Official title:
Effect of a Double Trunk Mask Associated to Nasal Prongs During a High Flow Oxygenation Method
Verified date | October 2017 |
Source | Laboratory of Movement, Condorcet, Tournai, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the effect (on PaO2) of a modified mask associated to nasal cannula used for high flow oxygenation.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 2, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Regardless of gender, at least 18 years of age and diagnosed with severe Hypoxia (PaO2/FiO2 < 300 mm Hg), dyspnea with severe rest at stake accessory muscles of respiration, respiratory rate (RR) = 25 CPM, PaCO2 = 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale = 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel. Exclusion Criteria Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), cardiogenic pulmonary edema, COPD, pulmonary fibrosis, hypoventilation obesity syndrom, arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale < or = 12), acute confusional state. Participants were randomized in a 1:1 ratio to receive either (CHFONP) classical High Flow Oxygenation with nasal prongs (20 minutes) or CHFNOP with an adjunctive of a DTM. |
Country | Name | City | State |
---|---|---|---|
Belgium | epicura Hornu | Hornu | Hainaut |
Lead Sponsor | Collaborator |
---|---|
Laboratory of Movement, Condorcet, Tournai, Belgium |
Belgium,
Chechani V, Scott G, Burnham B, Knight L. Modification of an aerosol mask to provide high concentrations of oxygen in the inspired air. Comparison to a nonrebreathing mask. Chest. 1991 Dec;100(6):1582-5. — View Citation
Hnatiuk OW, Moores LK, Thompson JC, Jones MD. Delivery of high concentrations of inspired oxygen via Tusk mask. Crit Care Med. 1998 Jun;26(6):1032-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of blood oxygenation (PaO2) after adjunction of a double trunk mask to a high flow oxygen canulae | The primary endpoint was the change of PaO2. Sequence (Figure 1): The patient should be placed in semi-seated (position at 45 °) Patient will be oxygenated with high-fow nasal cannula (HFNC). Fraction delivered in Oxygen and flow rate will be adjusted to obtain a Saturation in oxygen > at 90%. Arterial gazometry will be taken after 20 and 60 minutes wih HFNC. The clinician will associate the Double Trunk Mask (DTM) with the same parameters of the high-fow nasal cannula. Arterial gazometry will be performed after 20 and 60 minutes after placement of DTM. After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 minutes |
4 hours |
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