Health TrialsbyHealthPanel

Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates

ConditionsOxygen ToxicityCOPD BronchitisRespiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University

About this trial

Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .

The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).

secondary objective).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (> or = 18 years old)

Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter

SpO2 < 92% ambient air with the usual oximeter

Disqualifiers

No SpO2 signal with with the usual oximeter

False nails or nail polish

Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)

Oxygen flow > 6 L/min

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nasal canula - up to 6 liters per minute

    Device

    Oxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

  • Nasal canula - up to 15 liters per minute

    Device

    Oxygen will be administered via nasal cannula up to 15 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

  • Open oxygen mask

    Device

    Oxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

  • Simple oxygen face mask

    Device

    Oxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Nellcor oximeterOther 4 interventions
Group B: Nonin OximeterOther 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen flow

Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces

Time frame
Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)

Secondary outcomes

1

Partial oxygen weaning

Rate of partial oxygen weaning (Oxygen flow \<=0.5 L/min)

Time frame
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
2

Complete oxygen weaning

Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)

Time frame
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

Other outcomes

1

Gaps between the different oximeters

Average of the SpO2 value gaps between the different oximeters tested

Time frame
through period completion, minute 15
2

Gaps between PaCO2

PaCO2 value at the end of the period

Time frame
through period completion, minute 15

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: