Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients

Not Applicable

Completed

• Conditions: Post-operative Pulmonary Complications
• Interventions: Other: Standard oxygen therapy; Device: Heated humified high-flow nasal cannula Oxygen

• Registration Number: NCT03024112
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length of stay.

Detailed Description

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce ICU and hospital length of stay.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Results First Submitted: 2017-05-25
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-04
• Last Update Submitted: 2017-12-04
• Results First Posted: 2017-12-05
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Undergoing Thoracic surgery
• Planned admission to ICU after surgery

Exclusion Criteria

• Younger than 18
• Pregnant
• Breast feeding
• Known diagnosis of obstructive sleep apnea
• Current or previous lung transplant
• Pneumonectomy
• Home oxygen greater than 4L/minute
• Inability to adhere to assigned treatment prior to 48 hours of surgery or until transferred to a floor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oxygen Therapy	Standard oxygen therapy	The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.
Heated humidified high-flow nasal cannula (HHFNC) oxygen	Heated humified high-flow nasal cannula Oxygen	The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-operative Pulmonary Complications	30 days	The primary outcome "post-operative pulmonary complication" is defined as present if any one of the following criteria are met: * SpO2 \< 90% with FiO2 ≥ 50%; * Dyspnea at rest; * Respiratory rate \> 25 breaths/min; * Active use of accessory respiratory muscles; * PaO2/FiO2 ratio \< 200; * Escalation of therapy to non-invasive ventilation; * Re-intubation; * Occurrence of hospital-acquired pneumonia; * Re-admission to the ICU

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay	30 days
Hospital Length of Stay	30 days	length of stay from hospital admission to hospital discharge
Lowest Oxygen Saturation Level Measured	30 days	Lowest oxygen saturation level measured during hospitalization from admission to discharge

Trial Locations

Locations (1)

Unversity of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States