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Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia

ConditionOxygenation Index
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorChina Medical University, China

About this trial

This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age not less than 65 years

American Society of Anesthesiologists grades I-III

No history of drug allergies or abnormal anesthesia.

The duration of mechanical ventilation was expected to be more than 2 hours.

Disqualifiers

History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.

Cardiac function Class IV (New York Heart Association classification)

Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease

Patients with blurred consciousness and cognitive dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • 80% Oxygen

    Drug

    After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.

  • 40% Oxygen

    Drug

    After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.

Treatment groups

1,176 Participants
are divided into 2 treatment groups
Group A: Control: 80% OxygenPlacebo comparator 1 intervention
Group B: Experimental: 40% OxygenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation Index

The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.

Time frame
On the postoperative 48th hour

Secondary outcomes

1

pH value in blood gas analysis 48 hours after the operation

pH of blood gas analysis 48 hours after the operation

Time frame
On the postoperative 48th hour
2

oxygen inhalation time

oxygen inhalation time

Time frame
On the postoperative 48 hour
3

inspired oxygen concentration

inspired oxygen concentration

Time frame
On the postoperative 48 hour
4

oxygen uptake rate

oxygen uptake rate

Time frame
On the postoperative 48 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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