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

NCT06044402 | Unknown

• 1 other identifier: GanSu Province Hospital
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (10)

• PaO2/FiO2

  the outcome in mmHg

  the lowest value at one hour after extubation, day-1 to day-3

• hypoxemia

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• pneumonia

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• bronchospasm

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• atelectasis

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• pulmonary congestion

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• respiratory failure

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• pleural effusion

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• pneumothorax

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

• unplanned requirement for postoperative invasive or noninvasive ventilation

  the outcome in fraction

  From date of patient admission until the date of discharge, assessed up to 7 days

Secondary Outcomes (29)

• Tidal volume

  before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)

• respiratory rate

  before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)

• dead space fraction

  before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)

• A-aDO2

  before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)

• intrapulmonary shunt

  before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)

Study Arms (2)

group L

PLACEBO COMPARATOR

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.

Other: group L (Vt 6 ml/kg)

group I

EXPERIMENTAL

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.

Other: group I (Vt 8 ml/kg)

Interventions

group L (Vt 6 ml/kg) OTHER

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

group L

group I (Vt 8 ml/kg) OTHER

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

group I

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• dong zhang: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, double-blind, controlled trial

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: October 8, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09