Nocturnal Transnasal Insufflation (nTNI)

NCT ID: NCT01499550

Last Updated: 2012-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNI application

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

Group Type: EXPERIMENTAL

humidified transnasal insufflation (TNI20oxy)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

overnight oxygen treatment with individual flow rate

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

TNI20oxy

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TNI Medical AG

INDUSTRY

Sponsor Role: collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius

Head of the Department of pneumology at Helios Klinik Ambrock

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen

Locations

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

nTNI2011

Identifier Type: -

Identifier Source: org_study_id