Nocturnal Transnasal Insufflation (nTNI)

Not Applicable

Completed

• Conditions: COPD; Hypercapnia
• Interventions: Device: humidified transnasal insufflation (TNI20oxy); Other: overnight oxygen treatment with individual flow rate

• Registration Number: NCT01499550
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TNI application	humidified transnasal insufflation (TNI20oxy)	In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min).
Oxygen treatment	overnight oxygen treatment with individual flow rate	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.

Primary Outcome Measures

Name	Time	Method
PCO2 decrease	within 2 days	During the study nights the patients PCO2 value is measured transcutaneous as well as by capillary blood gas analyses (BGA) in the evening and in the morning. The differences in PCO2 values of the morning BGA will be compared, a PCO2 decrease is supposed to be assessed under TNI treatment.

Secondary Outcome Measures

Name	Time	Method
Changes of breathing pattern	within 2 days	Changes of breathing pattern and breahing frequency will be recorded during the nights and means and course evaluated. Breathing Frequency is supposed to decrease under TNI treatment

Trial Locations

Locations (1)

Helios Klinik Hagen Ambrock; 🇩🇪 Hagen, NRW, Germany