Nocturnal Transnasal Insufflation (nTNI)

NCT01499550 | Completed

• 1 other identifier: nTNI2011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Hypercapnia

Keywords

transnasal high flow therapy; COPD

Outcome Measures

Primary Outcomes (1)

• PCO2 decrease

  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.

  within 2 days

Secondary Outcomes (1)

• Changes of breathing pattern

  within 2 days

Study Arms (2)

TNI application

EXPERIMENTAL

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

Device: humidified transnasal insufflation (TNI20oxy)

Oxygen treatment

ACTIVE COMPARATOR

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.

Other: overnight oxygen treatment with individual flow rate

Interventions

humidified transnasal insufflation (TNI20oxy) DEVICE

The alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.

Also known as: TNI20oxy

TNI application

overnight oxygen treatment with individual flow rate OTHER

The patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.

Oxygen treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Before known obstructive sleep apnea syndrome (OSA)
• Any other severe or acute physical illness which requires intensive medical care
• Acute hypercapnic decompensation with pH \< 7.30 in capillary Blood Gas Analysis

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• TNI Medical AG: collaborator

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Georg Nilius, MD

  Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of pneumology at Helios Klinik Ambrock

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: December 26, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

DE (1)