Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation (HiFiPPS)

University of Freiburg

Status: Completed

Conditions: Respiratory Insufficiency

Treatments: Other: High Flow nasal cannula; Other: Standard respiratory care

Study type: Interventional

Funder types: Other

Identifiers

NCT02930525

143/16

Details and patient eligibility

About

Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events. We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).

Enrollment: 50 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 6 years - 18 years
2. Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
3. Informed consent/assent for enrollment by parents/legal guardians/patient

Exclusion criteria

1. Congenital or acquired malformations involving the airways
2. Patients with the history of spontaneous pneumothorax or connectives tissue diseases (Marfan syndrome, Ehlers-Danlos-Syndrome)
3. Patients with a history of traumatic/iatrogenic air leak within the last 3 months before enrollment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard care

Active Comparator group

Description:

Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.

Treatment:

Other: Standard respiratory care

High Flow nasal cannula

Experimental group

Description:

Application of humidified heated ambient air with flow rates adapted to body weight of respective subject. Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).

Treatment:

Other: High Flow nasal cannula