Nocturnal Transnasal Insufflation (nTNI)

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Hypercapnia; COPD

Treatments: Device: humidified transnasal insufflation (TNI20oxy); Other: overnight oxygen treatment with individual flow rate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499550

nTNI2011

Details and patient eligibility

About

On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.

Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.

Enrollment: 31 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypercapnia in Routine Blood Gas Analysis with > 50 mmHg PCO2
• Clinically stable respiratory situation
• Treatment on normal ward possible

Exclusion criteria

• Before known obstructive sleep apnea syndrome (OSA)
• A found OSA during study means no exclusion
• Any other severe or acute physical illness which requires intensive medical care
• Acute hypercapnic decompensation with pH < 7.30 in capillary Blood Gas Analysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31 participants in 2 patient groups

TNI application

Experimental group

Description:

In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min).

Treatment:

Device: humidified transnasal insufflation (TNI20oxy)

Oxygen treatment

Active Comparator group

Description:

Long term oxygen treatment (LOT) is the routine treatment in patients suffering from COPD. In this study arm the patient is treated with his individual oxygen flow rate.

Treatment:

Other: overnight oxygen treatment with individual flow rate