Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

NCT ID: NCT06044402

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2024-12-30

Brief Summary

The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.

Conditions

Trendelenburg; Neumoperitoneum; Oxygenation; Respiratory; Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group L

Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg.

Group Type: PLACEBO_COMPARATOR

group L (Vt 6 ml/kg)

Intervention Type: OTHER

low tidal volume ventilation (tidal volume was set to 6 ml/kg)

group I

Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg.

Group Type: EXPERIMENTAL

group I (Vt 8 ml/kg)

Intervention Type: OTHER

intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

Interventions

group L (Vt 6 ml/kg)

low tidal volume ventilation (tidal volume was set to 6 ml/kg)

Intervention Type: OTHER

group I (Vt 8 ml/kg)

intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I-III class;
• Colorectal cancer patients;
• Elective laparoscopic colorectal surgery;
• expected duration of surgery greater than 2 hours.

Exclusion Criteria

• serious complications associated with other systems;
• severe cardiac insufficiency;
• renal failure;
• body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
• the use of low tidal volume and consequent hypercapnia can induce harm;
• refusal to participate in the study.

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

dong zhang

OTHER

Sponsor Role: lead

Responsible Party

dong zhang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

GanSu Province Hospital

Identifier Type: -

Identifier Source: org_study_id