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Clinical Trials/CTRI/2019/05/018906
CTRI/2019/05/018906CompletedNot Applicable

To study the changes in endotracheal tube cuff pressure during abdominal surgery, with or without pneumoperitoneum.

Rajiv Gandhi Cancer Institute And Research Center1 site in 1 country120 target enrollmentStarted: May 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Changes in endotracheal tube cuff pressure during abdominal surgery with pneumoperitoneum.

Study Overview

Brief Summary

This is a hospital-based, prospective, observational, cohort study comparing the changes in the endotracheal tube cuff pressure in 60 cases of abdominal surgeries requiring pneumoperitoneum with 60 cases of open abdominal surgeries. Our primary objective is to study how pneumoperitoneum effects endotracheal tube cuff pressure and secondary objective is to correlate the changes in endotracheal tube cuff pressure with BMI and airway pressure, at different different time points during the surgery.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA GRADE I & II.
  • •DURATION OF SURGERY MORE THAN 2 HOURS.
  • •ABDOMINAL SURGERY REQUIRING LITHOTOMY POSITION.

Exclusion Criteria

  • •ASA Grade III & IV.
  • •Respiratory disorders.
  • •N2O Administration.

Outcomes

Primary Outcomes

Changes in endotracheal tube cuff pressure during abdominal surgery with pneumoperitoneum.

Time Frame: T0 After intubation,T1 Before lithotomy, T2 After lithotomy, T3 Before pneumoperitoneum, T4 Just after pneumoperitoneum,T5 5minutes after pneumoperitoneum, T6a 30mins, T6b 60mins, T6C 90mins, T6d 120mins, T6e 150mins,T6f 180mins,T7 Before the release of pneumoperitoneum, T8 After the release of pneumoperitoneum, T9 Supine position, T10 Before extubation.

Secondary Outcomes

  • Changes in endotracheal tube cuff pressure during open abdominal surgery.(T0 After intubation,T1 Before lithotomy, T2 After lithotomy, T3 Before incision, T4 Just after incision,T5 5minutes after incision, T6a 30mins, T6b 60mins, T6C 90mins, T6d 120mins, T6e 150mins,T6f 180mins,T7 Before the closure, T8 After the closure, T9 Supine position, T10 Before extubation.)

Investigators

Sponsor
Rajiv Gandhi Cancer Institute And Research Center
Sponsor Class
Research institution and hospital

Study Sites (1)

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