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High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03229460
Enrollment
150
Registered
2017-07-25
Start date
2019-08-31
Completion date
2019-12-31
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure With Hypercapnia

Brief summary

The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.

Detailed description

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Interventions

OTHERstandard low flow therapy

In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.

The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

DEVICEassociation of high flow nasal oxygen therapy and non invasive positive pressure ventilation

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Hypoxemic and no hypercapnic acute respiratory failure : * severe dyspnea at rest with a respiratory rate \>25 breaths/min * PaO2/FiO2 \<300 * PaCO2 \<45 mmHg,

Exclusion criteria

* age \<18 years * NPPV contraindications * past history of respiratory chronic disease (COPD, cystic fibrosis…) * cardiac pulmonary edema * Pre-defined intubation * other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12) * profound aplasia (white cells count \<1000/mm 3)

Design outcomes

Primary

MeasureTime frameDescription
the number of patients in each group who require endotracheal intubation with mechanical ventilation28daysTo compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

Secondary

MeasureTime frame
mechanical ventilation-free to day 2828 days

Countries

China

Contacts

Primary Contactbin he
hebinicu@139.com021-25077828
Backup Contactdongjuan tang
317582862@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026