Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency

August 21, 2018 updated by: Vijaya P Patil, Tata Memorial Hospital

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured.

Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel and additional suctioning if required.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be selected in Tata Memorial Hospital (TMH), Mumbai. 30 patients will be supplied through humidified oxygen using FISHER & PAYKEL MR 370 Heated Humidifier(HH) & 30 patients through conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. Continuous monitoring of temperature will be done using standard monitor.

The reusable HH will be subjected to disinfection between patients. Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel.

Based on patient's clinical condition , additional suctioning will be done. Frequency of additional suctioning , reason for suctioning will be noted.

Information regarding the age, sex, type of surgery of the patient, co-morbidity if any size of ETT, the time of commencement of humidification , duration of use of humidifier, time of extubation, any complication leading to discontinuation of humidifier, frequency of refilling of nebulizer chamber, volume of ETT before intubation etc. will be noted.

The amount of Endotracheal tube blockade caused by secretion will be measured immediately following extubation.

The volume of Endotracheal tube secretion / amount of blockade will be assessed by the following process-

  • The bevel end & Murphy's eye of the Endotracheal tube will be sealed using sterile insulating tape so that it become water tight. The tube will be gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold will be measured & noted.
  • The volume of extubated tube will be measured in the similar way.
  • The measured volume of the Extubated Endotracheal tube will be subtracted from the actual volume of the particular Sized ETT ( measured before intubation).
  • The result obtained after this subtraction will be the volume of secretion or the volume of ETT that has been blocked.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
  2. Undergoing surgery for head and neck cancer
  3. Requiring overnight endotracheal tube & breathing spontaneously

Exclusion Criteria:

  1. Patients with major cardiac diseases( coronary artery disease, Valvular diseases)
  2. Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis.
  3. Smokers(abstinence period less than 3 months)
  4. Patient in drugs having sialogogue properties.
  5. Patient on drugs having anti-sialogogue properties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heated humidifier group
30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.
Device: heated humidifier
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)
Active Comparator: Mist humidifier group
30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.
Device: mist humidifier
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume
Time Frame: At baseline just before intubation and 24 hours from time of ICU admission
The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted
At baseline just before intubation and 24 hours from time of ICU admission
Assess the Increase in Nurses Work Load
Time Frame: At baseline just before intubation and 24 hours from time of ICU admission
Investigators will assess nursing workload by frequency of filling of humidifier chamber.
At baseline just before intubation and 24 hours from time of ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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