Effects of Recruitment Maneuver During Intraoperative Period

NCT04239547 | Completed

• 1 other identifier: osagir-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.

Conditions

Laparoscopic Hysterectomy

Keywords

recruitment; pulmonary complication; oxygenisation

Outcome Measures

Primary Outcomes (3)

• measurement of change in airway compliance

  the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.

  T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation

• measurement of change in Airway resistance

  the patients airway compliance will be monitorised as centimeter of water/ liter/ minute (cmH2O/L/min) continuously by the anesthesia machine and will be recorded intermittently.

  T1:1 minute after intubationT2:5 min after MV T3:5 minute after pneumoperitoneum T4:3 minute after Trendelenburg position (TP) T5:10 minutes after TP T6:20 minutes after TP T7:10 minutes after pneumoperitoneum deflation T8:1 minute before extubation

• measurement of change in partial oxygen pressure (PaO2)

  Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.

  T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation

Secondary Outcomes (1)

• Evaluation of Postoperative respiratory distress, cough, phlegm

  T9: 24 hours after surgery . T10: on postoperative day 5

Study Arms (2)

Recruitment

EXPERIMENTAL

Patients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.

Procedure: Alveolar Recruitment maneuver (ARM) +PEEP

Non-recruitment

EXPERIMENTAL

Patients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.

Procedure: PEEP

Interventions

Alveolar Recruitment maneuver (ARM) +PEEP PROCEDURE

Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP

Recruitment

PEEP PROCEDURE

Following anesthesia induction and intubation, only 5 mmHg PEEP

Non-recruitment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) I-II
• \> 18 y
• laparoscopic hysterectomy patients

You may not qualify if:

• Patient refusal to participate in the study
• \<18 y, BMI\> 40
• Patients receiving invasive MV support in the last 1 month
• Patients who received chemotherapy or radiotherapy in the last 2 months
• Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
• Those with known severe pulmonary Hypertension
• Intracranial tm
• Hemodynamic instability
• Shock.
• Neuromuscular disease

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, the participant and outcomes assessor will be masked to the intervention. Only the caregiver will be aware of the group and intervention received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: November 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

TU (1)