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

Primary Purpose

Cancer of Head and Neck

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
heated humidifier
mist humidifier
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Head and Neck

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Heated humidifier group

    Mist humidifier group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume
    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
    Assess the Increase in Nurses Work Load
    Investigators will assess nursing workload by frequency of filling of humidifier chamber.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 11, 2016
    Last Updated
    August 21, 2018
    Sponsor
    Tata Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02780765
    Brief Title
    Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency
    Official Title
    Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tata Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer of Head and Neck

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Heated humidifier group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Mist humidifier group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    heated humidifier
    Intervention Description
    30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)
    Intervention Type
    Device
    Intervention Name(s)
    mist humidifier
    Intervention Description
    30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
    Primary Outcome Measure Information:
    Title
    Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume
    Description
    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
    Time Frame
    At baseline just before intubation and 24 hours from time of ICU admission
    Title
    Assess the Increase in Nurses Work Load
    Description
    Investigators will assess nursing workload by frequency of filling of humidifier chamber.
    Time Frame
    At baseline just before intubation and 24 hours from time of ICU admission

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients Undergoing surgery for head and neck cancer Requiring overnight endotracheal tube & breathing spontaneously Exclusion Criteria: Patients with major cardiac diseases( coronary artery disease, Valvular diseases) Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis. Smokers(abstinence period less than 3 months) Patient in drugs having sialogogue properties. Patient on drugs having anti-sialogogue properties

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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