The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy

Yale University

Status and phase: Withdrawn; Phase 4

Conditions: Hyperoxia

Treatments: Drug: 60% oxygen; Drug: 100% oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02509182

1507016157

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that decreasing the inspired oxygen concentration during thoracic surgery requiring one lung ventilation will improve post-operative oxygenation.

Full description

One lung ventilation is frequently required during thoracic surgery and results in decreased lung function post-operatively. Supra-physiologic oxygen levels during surgery may contribute to this decrease in lung function by worsening lung injury intra-operatively.

This study will include patients undergoing surgery to remove a lung lobe requiring one lung ventilation.

The patients will be divided into two groups with the experimental group receiving a 60% oxygen in air mixture and the control group receiving 100% oxygen.

The two groups will be compared by using a measure of lung function (the ratio of the partial pressure of oxygen in arterial blood to the inspired oxygen concentration) and blood levels of a protein correlated with lung injury (receptor of advanced glycation end products RAGE).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults, 18 years of age and older, male or female.
2. American Society of Anesthesiology (ASA) physical status I, II, III or IV
3. Subjects who are scheduled for elective primary pulmonary lobectomy.
4. Subjects who have an arterial line placed as part of routine anesthetic management
5. Subjects who can understand and communicate in English.

Exclusion criteria

1. Subjects with a history of difficult intubation
2. Subjects with a high risk of aspiration during induction of anesthesia
3. Subjects with morbid obesity (BMI greater than or equal to 40)
4. Subjects with unable to provide consent
5. Subjects who are minors
6. Subjects who are not English speaking

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

100% FiO2

Active Comparator group

Description:

100% oxygen administered during pulmonary lobectomy surgery.

Treatment:

Drug: 100% oxygen

60% FiO2

Experimental group

Description:

60% oxygen administered during pulmonary lobectomy surgery.

Treatment:

Drug: 60% oxygen