Randomised controlled trial of low-pressure ventilation intervention for blood loss in ovarian tumour surgery.

JRCT ID: jRCT1032240506

Registered date:26/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ovary Cancer
• Date of first enrollment: 01/04/2024
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Low-pressure ventilation and low venous pressure interventions are continued from the start of surgery until the end of surgery.
The intervention group is managed with zero PEEP and TV 6 ml/kg, and preferentially with norepinephrine and no artificial colloidal fluid for pressure boosting purposes.

Outcome(s)

• Primary Outcome: intraoperative blood loss

Secondary Outcome

Estimated blood loss
Perioperative transfusion volume and transfusion rate
Estimated and actual ascites volume
Postoperative chest x-ray for atelectasis
Estimated blood loss at 1 week post-operatively
Respiratory events at 1 week postoperatively
Postoperative complications Clavien-Dindo classification at 1 week and 30 days
Length of hospital stay
In-hospital mortality

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 100age old
• Gender: Female
• Include criteria: Patients undergoing ovarian cancer surgery at Chiba University Hospital.

Exclude criteria

1.Minors
2.Emergency surgery
3.Patients for whom an experimental laparotomy will be performed in this surgery
4.Obese with a BMI of 30 or more
5.Patients diagnosed with chronic obstructive pulmonary disease
6. Patients under treatment for asthma (included in eligible patients if only pre-existing)
7.Patients with complications of heart failure
8.Patients with severe sleep apnoea syndrome
9.Smokers (if they have not stopped smoking for at least one month)
10.Anaemia Hb <9g/dl
11.Coagulation abnormalities APTT > 42 seconds, PT > 17 seconds
12.Platelets <100,000
13.Patients with preoperative physical status 4 or 5 of the American Society of Anaesthesiologists
14.Patients with a history of laparotomy (excluding exploratory laparotomy due to ovarian cancer)
15.Patients with ChildB or C cirrhosis
16.Patients deemed unsuitable as subjects by the principal (sub)investigator

Related Information

• Primary Sponsor: Kyongsuk Son
• Secondary ID(s): UMIN000053995