Nocturnal Transnasal Insufflation (nTNI)

This study has been completed.
Sponsor:
Collaborator:
TNI Medical AG
Information provided by (Responsible Party):
Georg Nilius, Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier:
NCT01499550
First received: November 3, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
COPD
Hypercapnia
Device: humidified transnasal insufflation (TNI20oxy)
Other: overnight oxygen treatment with individual flow rate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia

Resource links provided by NLM:


Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • PCO2 decrease [ Time Frame: within 2 days ] [ Designated as safety issue: No ]
    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:
  • Changes of breathing pattern [ Time Frame: within 2 days ] [ Designated as safety issue: No ]
    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


Enrollment: 31
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNI application
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)
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.
Other Name: TNI20oxy
Active Comparator: Oxygen treatment
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01499550

Locations
Germany
Helios Klinik Hagen Ambrock
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
TNI Medical AG
Investigators
Principal Investigator: Georg Nilius, MD Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen
  More Information

No publications provided

Responsible Party: Georg Nilius, Head of the Department of pneumology at Helios Klinik Ambrock, Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01499550     History of Changes
Other Study ID Numbers: nTNI2011
Study First Received: November 3, 2011
Last Updated: September 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
transnasal high flow therapy
COPD

Additional relevant MeSH terms:
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014