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

Post-operative Pulmonary Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024112
• Other study ID #: 12-1403
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: December 4, 2017
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-operative Pulmonary Complications

Intervention

Device:
• Heated humified high-flow nasal cannula Oxygen

Other:
• Standard oxygen therapy

Locations

Country	Name	City	State
United States	Unversity of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Post-operative Pulmonary Complications	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	30 days
Secondary	Hospital Length of Stay	length of stay from hospital admission to hospital discharge	30 days
Secondary	Lowest Oxygen Saturation Level Measured	Lowest oxygen saturation level measured during hospitalization from admission to discharge	30 days
Secondary	ICU Length of Stay		30 days