High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
1 other identifier
interventional
94
1 country
1
Brief Summary
The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedDecember 24, 2018
December 1, 2018
2.7 years
August 26, 2015
December 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
during the first 96 hours after surgery
Secondary Outcomes (4)
Number of patients with SpO2 <93% in room air
after 48 hours from surgery and until 7th post operative day
Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure
during the first 7 days after surgery
Postoperative pulmonary complications
during the first 7 days after surgery
Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)
during the first 96 hours after surgery
Study Arms (2)
High-flow nasal cannula oxygen (HFNCO)
EXPERIMENTALPatients will receive HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%.
standard oxygen therapy
ACTIVE COMPARATORPatients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%.
Interventions
Eligibility Criteria
You may qualify if:
- planned pulmonary lobectomy for lung cancer
You may not qualify if:
- age \<18 years
- patient refusal
- body mass index ≥35 kg/m2
- sleep apnea syndrome
- tracheostomy
- home oxygen therapy
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
Related Publications (1)
Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5.
PMID: 30819227DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 9, 2015
Study Start
August 1, 2015
Primary Completion
April 1, 2018
Study Completion
September 1, 2018
Last Updated
December 24, 2018
Record last verified: 2018-12