Nocturnal Transnasal Insufflation (nTNI)
Primary Purpose
COPD, Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
humidified transnasal insufflation (TNI20oxy)
overnight oxygen treatment with individual flow rate
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring transnasal high flow therapy, COPD
Eligibility 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
Sites / Locations
- Helios Klinik Hagen Ambrock
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TNI application
Oxygen treatment
Arm Description
In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes of breathing pattern
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
Full Information
NCT ID
NCT01499550
First Posted
November 3, 2011
Last Updated
September 24, 2012
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
TNI Medical AG
1. Study Identification
Unique Protocol Identification Number
NCT01499550
Brief Title
Nocturnal Transnasal Insufflation (nTNI)
Official Title
Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
TNI Medical AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnia
Keywords
transnasal high flow therapy, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNI application
Arm Type
Experimental
Arm Description
In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min).
Arm Title
Oxygen treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
humidified transnasal insufflation (TNI20oxy)
Other Intervention Name(s)
TNI20oxy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
overnight oxygen treatment with individual flow rate
Intervention Description
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.
Primary Outcome Measure Information:
Title
PCO2 decrease
Description
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.
Time Frame
within 2 days
Secondary Outcome Measure Information:
Title
Changes of breathing pattern
Description
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
Time Frame
within 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany
12. IPD Sharing Statement
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Nocturnal Transnasal Insufflation (nTNI)
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